Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.

Name: Kaimen Rigor review — Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.
Item: Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.
Rating: 39
Author: Alpha1

Anter E, Mansour M, Nair DG, Sharma D, Taigen TL, Neuzil P, Kiehl EL, Kautzner J, Osorio J, Mountantonakis S, Natale A, Hummel JD, Amin AK, Siddiqui UR, Harlev D, Hultz P, Liu S, Onal B, Tarakji KG, Reddy VY, SPHERE PER-AF Investigators

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Kaimen Rigor review — 1★ (Critical), 1 critical, 4 high issues for “Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

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Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.

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DOI

10.1038/s41591-024-03022-6

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.

Paper source

Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

1 / 5

Critical — a demonstrable failure

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsImpossible or misreported statistic ×2−2★
IntegrityIntegrity concern ×2−1★
ClaimsUnsupported claim (uncorroborated)−0.5★
ReportingData & code availability partially met−0.25★

A demonstrable critical failure caps the rating at the minimum, regardless of the deductions above.

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 32 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.

Biggest issues2 demonstrable

01Significance claim does not survive recomputationdemonstrable
criticalOverreachrecomputedFull detail
Primary effectiveness non-inferiority p-value from Farrington-Manning test
“The observed difference in primary effectiveness success was 8.0% in favor of the investigational arm (95% confidence interval (CI): −0.9% to 16.8%), meeting the criteria for non-inferiority ( P < 0.0001; Table and Fig. ).”
Find in source
02Significance claim does not survive recomputationdemonstrable
criticalOverreachrecomputedFull detail
Primary safety non-inferiority p-value from Farrington-Manning test
“Primary safety events occurred in three (1.4%) patients in the investigational arm and in two (1.0%) patients in the control arm (difference: 0.4%; 90% CI: −2.8% to 3.7%; P < 0.0001 for non-inferiority; Table ).”
Find in source
03Conclusion not supported by the paper’s own evidence
highOverreachreviewer-assessedFull detail
The investigational device is superior in effectiveness.
“Pre-specified superiority testing did not demonstrate superiority of the primary effectiveness endpoint in the investigational arm compared to the control arm (two-sided P = 0.078, which was greater than the two-sided alpha of 0.05; Fig. ).”
ResultsFind in source

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 103AuthenticityData authenticity concerns 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit6 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-designed and well-reported randomized non-inferiority trial with strong methodological reporting across most dimensions. The primary concern is the statistical verification finding that two reported non-inferiority p-values are inconsistent with recomputation, which is a demonstrable error that warrants correction or clarification. Data availability is vague and the reporting guideline is not explicitly stated.

Both reviewers agreed on study type (interventional) and on all dimensions except minor checklist-level divergences (controls, reporting guideline) that do not affect statuses. The statistics verification recomputed only two primary non-inferiority p-values; all other reported statistics (secondary endpoints, CIs) were not machine-verified and should be treated as unverified. The integrity check flagged a low-severity internal contradiction regarding the abstract's description of enrollment vs. randomization, which is explained by the flow diagram.

Numerical inconsistencies

1 finding · worst low

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Recomputed 2 tests: 0 consistent, 2 inconsistent (2 change significance at p<.05); 2 via agent-written checks.

Overstated conclusions

2 findings · worst critical

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Significance claim flips when recomputedRecomputed
Conclusions not supported by the paper’s own evidenceAssessed

6 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

1 finding · worst low

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Other integrity concernAssessed

2 integrity concerns flagged (0 high).

Reporting gaps

1 finding · worst medium

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

The introduction cites multiple prior studies on AF ablation limitations and the development of the lattice-tip catheter, acknowledging both strengths and weaknesses of existing technologies. The rationale for the trial is clearly linked to the need for more durable lesions and improved procedural efficiency. Limitations of prior research are addressed through the trial design and discussion.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with extensive prior work and a logical rationale for the study.

Evidence

paraphrase[Introduction, paragraphs 1-3]

“Conventional catheter ablation technologies are optimized for treating paroxysmal AF but have major shortcomings in treating persistent AF.”

“Accordingly, SPHERE Per-AF was a randomized, single-blind, non-inferiority clinical trial that compared the lattice-tip dual-energy ablation platform with a conventional radiofrequency ablation platform in the treatment of drug-refractory persistent AF.”

IntroductionFind in source

paraphrase[Discussion, paragraph 1]

“Historical outcomes of catheter ablation in patients with persistent AF have been suboptimal, with 1-year success rates ranging between 45% and 62% in different multi-center trials.”

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with extensive prior work and a logical rationale for the study.

Evidence

paraphrase[Introduction, paragraphs 1-3]

“Conventional catheter ablation technologies are optimized for treating paroxysmal AF but have major shortcomings in treating persistent AF.”

IntroductionFind in source

paraphrase[Discussion, paragraph 1]

“Historical outcomes of catheter ablation in patients with persistent AF have been suboptimal, with 1-year success rates ranging between 45% and 62% in different multi-center trials.”

Randomization was blocked and stratified by site and neurological substudy, with patients blinded to assignment. The trial was single-blind (patients blinded; operators not), which is appropriate for a device trial. A power analysis was performed to determine sample size. Inclusion/exclusion criteria were pre-specified. The analysis population (ITT-like) and missing data handling are described. Controls are the conventional ablation system. Independent replication is not applicable for a pivotal trial.

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with clear randomization, blinding, power analysis, and pre-specified endpoints.

Evidence

“Randomization was completed via an electronic data capture system, where randomization was blocked and stratified by site and by enrollment in a neurological substudy.”

MethodsFind in source

“Randomized patients were blinded to their procedural assignment.”

MethodsFind in source

paraphrase[Methods, Statistical analysis]

“To achieve power greater than 80% for testing each primary endpoint using the Farrington–Manning method, a sample size of 350 evaluable patients (175 per arm) was required for the primary analysis cohort.”

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomization, blinding, power analysis, and pre-specified endpoints.

Evidence

“Randomization was completed via an electronic data capture system, where randomization was blocked and stratified by site and by enrollment in a neurological substudy.”

MethodsFind in source

“Randomized patients were blinded to their procedural assignment.”

MethodsFind in source

paraphrase[Methods, Statistical analysis]

Sex, age, BMI, comorbidities, and other relevant clinical variables are reported in Table 1. Since both sexes are enrolled, sex_justified is not applicable. Age, weight (BMI), and health status are reported. Demographics include race and comorbidities. Species/strain and housing are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic and clinical characteristics are well reported for both arms.

Evidence

“Age (years) | 67.8 ± 8.3 | 66.7 ± 8.8 | | Sex, male | 139 (65.6%) | 147 (70.7%)”

Table 1Find in source

“Race, White or Caucasian | 199 (93.9%) | 199 (95.7%)”

Table 1Find in source

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including sex, age, and comorbidities.

Evidence

“Age (years) | 67.8 ± 8.3 | 66.7 ± 8.8 | | Sex, male | 139 (65.6%) | 147 (70.7%)”

Table 1Find in source

“Race, White or Caucasian | 199 (93.9%) | 199 (95.7%)”

Table 1Find in source

The trial received approval from the FDA and institutional review boards at each center, and was conducted in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants. Regulatory compliance is stated. The data safety monitoring board and clinical events committee are described.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals and informed consent are clearly documented.

Evidence

“The trial received approval from the US Food and Drug Administration (FDA) and from the institutional review board at each participating center and was conducted in accordance with the principles of the Declaration of Helsinki.”

MethodsFind in source

“All study participants provided written informed consent.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approvals and informed consent are clearly documented.

Evidence

MethodsFind in source

“All study participants provided written informed consent.”

MethodsFind in source

The investigational device (Sphere-9 catheter, Medtronic) and control devices (Carto 3, THERMOCOOL SMARTTOUCH, Biosense Webster) are named with manufacturers. The mapping system is also identified. Statistical software (SAS 9.4) is identified. No antibodies, cell lines, or mycoplasma testing are applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational and control devices are identified with manufacturer and model, and software is identified.

Evidence

“The investigational technology includes a lattice-tip catheter (Sphere-9 catheter, Medtronic) with a compatible proprietary electro-anatomical mapping system (Affera Mapping and Ablation System, Medtronic)”

MethodsFind in source

“In the control arm, operators employed a commercially available technology comprising an electro-anatomical mapping system (Carto 3, Biosense Webster), a multi-electrode mapping catheter and a contact force-sensing ablation catheter (THERMOCOOL SMARTTOUCH, Biosense Webster)”

MethodsFind in source

“Statistical analyses were performed using the SAS version 9.4 software package (SAS Institute).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Investigational and control devices are identified with manufacturer and model, and software is identified.

Evidence

MethodsFind in source

“Statistical analyses were performed using the SAS version 9.4 software package (SAS Institute).”

Statistical analysisFind in source

The primary analysis uses Farrington–Manning non-inferiority tests, and secondary analyses use sequential testing and log-rank tests. Exact p-values are reported (e.g., P < 0.0001). Effect sizes with confidence intervals are provided for primary and secondary endpoints. Software is identified. Data presentation includes Kaplan-Meier curves and tables with per-group n. Mathematical plausibility checks are not applicable for large-N continuous outcomes.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals.

Evidence

“Trial success was defined by demonstrating both non-inferiority of the primary safety endpoint and non-inferiority of the primary effectiveness endpoint based on binomial proportions using the Farrington–Manning method.”

Statistical analysisFind in source

“The primary effectiveness endpoint success rate was 73.8% for the investigational arm and 65.8% for the control arm. The observed difference in primary effectiveness success was 8.0% in favor of the investigational arm (95% confidence interval (CI): −0.9% to 16.8%), meeting the criteria for non-inferiority ( P < 0.0001; Table and Fig. ).”

ResultsFind in source

“This included shorter total energy application time (7.1 ± 2.0 min versus 36.4 ± 17.7 min; difference: −29.2 min, 95% CI −31.7 to −26.8, P < 0.0001)”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals.

Evidence

Statistical analysisFind in source

ResultsFind in source

“This included shorter total energy application time (7.1 ± 2.0 min versus 36.4 ± 17.7 min; difference: −29.2 min, 95% CI −31.7 to −26.8, P < 0.0001)”

ResultsFind in source

The data availability statement says 'All supporting data are available within the article and the . Source data will not be shared due to patient privacy and informed consent.' This is vague and does not name a concrete access route or platform. No repository deposit or accession numbers are provided. Code availability states 'No custom code was used.'

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 85% conf

Data availability statement is present but vague; no repository deposit or accession numbers are provided.

Evidence

“All supporting data are available within the article and the . Source data will not be shared due to patient privacy and informed consent, including the potential for release of protected health information.”

Data availabilityFind in source

absence[Data availability]

No repository deposit is mentioned.

“No custom code was used.”

Data availabilityFind in source

WARNReviewer 2· 80% conf

Data availability statement is present but vague; no repository deposit or accession numbers; code sharing not applicable.

Evidence

Data availabilityFind in source

“No custom code was used.”

Data availabilityFind in source

The trial is registered (NCT05120193). Methods are detailed enough for replication. A reporting guideline is not explicitly mentioned, but the paper follows CONSORT-like structure. All pre-specified outcomes are reported, including negative results (superiority not demonstrated). Limitations are discussed. Conclusions are proportional to the evidence. Funding and COI are disclosed.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“ClinicalTrials.gov identifier: NCT05120193”

AbstractFind in source

“Our trial has several limitations. There is a potential for under-detection of asymptomatic atrial tachyarrhythmias due to the absence of continuous invasive monitoring.”

DiscussionFind in source

“E.A. is a consultant to and has received equity from Affera-Medtronic.”

Competing interestsFind in source

PASSReviewer 2· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“ClinicalTrials.gov identifier: NCT05120193 (https://classic.clinicaltrials.gov/ct2/show/NCT05120193)”

AbstractFind in source

“Our trial has several limitations. There is a potential for under-detection of asymptomatic atrial tachyarrhythmias due to the absence of continuous invasive monitoring.”

DiscussionFind in source

“E.A. is a consultant to and has received equity from Affera-Medtronic.”

Competing interests sectionFind in source

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 47 references by DOI: 45 verified — 2 no DOI (shown, not verified).

2 data/code links checked; 2 live.

Copyediting

6 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 6 minor suggestions below.

6 copyedit issues flagged: mostly consistency, clarity, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is largely robust, but the two inconsistent primary p-values are a substantive statistical concern that an informed reader should weigh heavily; they may warrant an erratum or independent re-analysis. The vague data availability statement and lack of explicit reporting guideline are minor reporting gaps that do not invalidate the study but reduce transparency.

1.
CRITICALstatistics
Resolve the statistics inconsistency that flips a significance claim: Recomputed 2 tests: 0 consistent, 2 inconsistent (2 change significance at p<.05); 2 via agent-written checks.
Demonstrable critical failure — blocks the verdict from passing.
2.
HIGHstatistics
Recompute and correct the reported p-values for the primary effectiveness and safety non-inferiority endpoints in the Results and Abstract; the recomputed values (P=0.076 and P=0.809) are inconsistent with the reported P<0.0001.
Two demonstrable p-value errors undermine the primary non-inferiority claims and require correction or clarification to avoid misleading readers.
3.
HIGHrigor
Clarify whether the reported non-inferiority p-values are actually for the Farrington-Manning test or for a different comparison; if the recomputed values are correct, the non-inferiority conclusion may not hold and the paper's headline claim must be revised.
The inconsistency between reported and recomputed p-values raises the possibility that the non-inferiority conclusion is not supported by the data.
4.
HIGHdata code
Complete the data availability statement in the Data availability section by specifying the supplementary information or repository link, and provide a concrete access route (e.g., managed-access platform or data access committee) for source data.
The current statement is incomplete and vague, failing to meet transparency standards for a clinical trial.
5.
HIGHreporting
Explicitly state adherence to the CONSORT reporting guideline in the Methods or provide a completed CONSORT checklist as supplementary material.
Explicit reporting guideline adherence strengthens transparency and reproducibility.
6.
MEDIUMreporting
Add a note in the Discussion about the generalizability of findings given the predominantly White/Caucasian cohort (93.9-95.7%).
The lack of diversity may limit generalizability, and acknowledging this is important for readers.
7.
MEDIUMreporting
Clarify the handling of missing data for the primary effectiveness analysis (e.g., sensitivity analyses) in the Methods.
The exclusion of 2 investigational and 6 control patients from the effectiveness analysis but not the safety analysis should be explicitly justified.
8.
MEDIUMreporting
Provide a CONSORT flow diagram with more detailed reasons for exclusions and dropouts, and clarify the discrepancy between 469 enrolled and 432 randomized in the abstract.
The large drop from enrollment to randomization may confuse readers; a detailed flow diagram improves transparency.
9.
MEDIUMreporting
State whether any deviations from the pre-specified statistical analysis plan occurred, and if so, describe them.
Transparency about protocol deviations is essential for clinical trial reporting.
10.
MEDIUMreporting
Provide more detail on the blinding of outcome assessors and core laboratories in the Methods.
Clarifying who was blinded beyond patients strengthens the description of blinding.
11.
LOWcopyedit
Fix the incomplete sentence in the Data availability section: 'All supporting data are available within the article and the .' by completing it with the specific supplementary information or repository.
The sentence is grammatically incomplete and should be corrected for clarity.
12.
LOWcopyedit
Remove the extra commas in the Methods, Interventions section: 'delivered for 4 s ,, .'
Extra punctuation is a minor copyedit issue that should be cleaned up.
13.
LOWcopyedit
Rephrase the sentence in the Discussion: 'The observed difference between the investigational and control arms was not driven by lower performance of the control arm.' for clarity.
The sentence is slightly awkward and could be clearer.

Full text (72,781 chars)Analyzed: Aug 16, 2026

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Dual-energy lattice-tip ablation system for persistent atrial fibrillation: a randomized trial.

Read full text (PMC)

DOI

10.1038/s41591-024-03022-6

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Record fingerprint

a5efe5c3e2cc1ff0207f140a09a48ae62633c46a52cb00ed5096c902edb277b2

Verify via API

Issued Aug 16, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

1 / 5

Critical — a demonstrable failure

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsImpossible or misreported statistic ×2−2★
IntegrityIntegrity concern ×2−1★
ClaimsUnsupported claim (uncorroborated)−0.5★
ReportingData & code availability partially met−0.25★

A demonstrable critical failure caps the rating at the minimum, regardless of the deductions above.

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 32 reported means were read, and their group size is not stated where the values are printed (this source has no machine-readable table structure). These checks need the count the mean was averaged over, so none was performed.

Biggest issues2 demonstrable

01Significance claim does not survive recomputationdemonstrable
criticalOverreachrecomputedFull detail
Primary effectiveness non-inferiority p-value from Farrington-Manning test
“The observed difference in primary effectiveness success was 8.0% in favor of the investigational arm (95% confidence interval (CI): −0.9% to 16.8%), meeting the criteria for non-inferiority ( P < 0.0001; Table and Fig. ).”
Find in source
02Significance claim does not survive recomputationdemonstrable
criticalOverreachrecomputedFull detail
Primary safety non-inferiority p-value from Farrington-Manning test
“Primary safety events occurred in three (1.4%) patients in the investigational arm and in two (1.0%) patients in the control arm (difference: 0.4%; 90% CI: −2.8% to 3.7%; P < 0.0001 for non-inferiority; Table ).”
Find in source
03Conclusion not supported by the paper’s own evidence
highOverreachreviewer-assessedFull detail
The investigational device is superior in effectiveness.
“Pre-specified superiority testing did not demonstrate superiority of the primary effectiveness endpoint in the investigational arm compared to the control arm (two-sided P = 0.078, which was greater than the two-sided alpha of 0.05; Fig. ).”
ResultsFind in source

Findings by category

101ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 103AuthenticityData authenticity concerns 104DisclosureReporting gaps 05AvailabilityNone found 06Copyedit6 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 2 tests: 0 consistent, 2 inconsistent (2 change significance at p<.05); 2 via agent-written checks.

Overstated conclusions

2 findings · worst critical

Significance claim flips when recomputedRecomputed
Conclusions not supported by the paper’s own evidenceAssessed

6 major claims checked against the paper's own evidence: 1 not fully backed by the presented evidence (unsupported or overstated).

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

1 finding · worst low

Other integrity concernAssessed

2 integrity concerns flagged (0 high).

Reporting gaps

1 finding · worst medium

Data/code availability incompleteAssessed

Eight Dimensions7 pass · 1 warn

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with extensive prior work and a logical rationale for the study.

Evidence

paraphrase[Introduction, paragraphs 1-3]

“Conventional catheter ablation technologies are optimized for treating paroxysmal AF but have major shortcomings in treating persistent AF.”

IntroductionFind in source

paraphrase[Discussion, paragraph 1]

“Historical outcomes of catheter ablation in patients with persistent AF have been suboptimal, with 1-year success rates ranging between 45% and 62% in different multi-center trials.”

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with extensive prior work and a logical rationale for the study.

Evidence

paraphrase[Introduction, paragraphs 1-3]

“Conventional catheter ablation technologies are optimized for treating paroxysmal AF but have major shortcomings in treating persistent AF.”

IntroductionFind in source

paraphrase[Discussion, paragraph 1]

“Historical outcomes of catheter ablation in patients with persistent AF have been suboptimal, with 1-year success rates ranging between 45% and 62% in different multi-center trials.”

Sub-criteria

controlsADEQUATE

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with clear randomization, blinding, power analysis, and pre-specified endpoints.

Evidence

“Randomization was completed via an electronic data capture system, where randomization was blocked and stratified by site and by enrollment in a neurological substudy.”

MethodsFind in source

“Randomized patients were blinded to their procedural assignment.”

MethodsFind in source

paraphrase[Methods, Statistical analysis]

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomization, blinding, power analysis, and pre-specified endpoints.

Evidence

“Randomization was completed via an electronic data capture system, where randomization was blocked and stratified by site and by enrollment in a neurological substudy.”

MethodsFind in source

“Randomized patients were blinded to their procedural assignment.”

MethodsFind in source

paraphrase[Methods, Statistical analysis]

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Demographic and clinical characteristics are well reported for both arms.

Evidence

“Age (years) | 67.8 ± 8.3 | 66.7 ± 8.8 | | Sex, male | 139 (65.6%) | 147 (70.7%)”

Table 1Find in source

“Race, White or Caucasian | 199 (93.9%) | 199 (95.7%)”

Table 1Find in source

PASSReviewer 2· 90% conf

Demographic and clinical characteristics are well reported, including sex, age, and comorbidities.

Evidence

“Age (years) | 67.8 ± 8.3 | 66.7 ± 8.8 | | Sex, male | 139 (65.6%) | 147 (70.7%)”

Table 1Find in source

“Race, White or Caucasian | 199 (93.9%) | 199 (95.7%)”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approvals and informed consent are clearly documented.

Evidence

MethodsFind in source

“All study participants provided written informed consent.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approvals and informed consent are clearly documented.

Evidence

MethodsFind in source

“All study participants provided written informed consent.”

MethodsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational and control devices are identified with manufacturer and model, and software is identified.

Evidence

MethodsFind in source

“Statistical analyses were performed using the SAS version 9.4 software package (SAS Institute).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Investigational and control devices are identified with manufacturer and model, and software is identified.

Evidence

MethodsFind in source

“Statistical analyses were performed using the SAS version 9.4 software package (SAS Institute).”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals.

Evidence

Statistical analysisFind in source

ResultsFind in source

“This included shorter total energy application time (7.1 ± 2.0 min versus 36.4 ± 17.7 min; difference: −29.2 min, 95% CI −31.7 to −26.8, P < 0.0001)”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and confidence intervals.

Evidence

Statistical analysisFind in source

ResultsFind in source

“This included shorter total energy application time (7.1 ± 2.0 min versus 36.4 ± 17.7 min; difference: −29.2 min, 95% CI −31.7 to −26.8, P < 0.0001)”

ResultsFind in source

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 85% conf

Data availability statement is present but vague; no repository deposit or accession numbers are provided.

Evidence

Data availabilityFind in source

absence[Data availability]

No repository deposit is mentioned.

“No custom code was used.”

Data availabilityFind in source

WARNReviewer 2· 80% conf

Data availability statement is present but vague; no repository deposit or accession numbers; code sharing not applicable.

Evidence

Data availabilityFind in source

“No custom code was used.”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“ClinicalTrials.gov identifier: NCT05120193”

AbstractFind in source

“Our trial has several limitations. There is a potential for under-detection of asymptomatic atrial tachyarrhythmias due to the absence of continuous invasive monitoring.”

DiscussionFind in source

“E.A. is a consultant to and has received equity from Affera-Medtronic.”

Competing interestsFind in source

PASSReviewer 2· 90% conf

The trial is registered, methods are detailed, limitations are discussed, and conclusions are proportional.

Evidence

“ClinicalTrials.gov identifier: NCT05120193 (https://classic.clinicaltrials.gov/ct2/show/NCT05120193)”

AbstractFind in source

“Our trial has several limitations. There is a potential for under-detection of asymptomatic atrial tachyarrhythmias due to the absence of continuous invasive monitoring.”

DiscussionFind in source

“E.A. is a consultant to and has received equity from Affera-Medtronic.”

Competing interests sectionFind in source

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 47 references by DOI: 45 verified — 2 no DOI (shown, not verified).

2 data/code links checked; 2 live.

Copyediting

6 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 6 minor suggestions below.

6 copyedit issues flagged: mostly consistency, clarity, grammar.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
CRITICALstatistics
Resolve the statistics inconsistency that flips a significance claim: Recomputed 2 tests: 0 consistent, 2 inconsistent (2 change significance at p<.05); 2 via agent-written checks.
Demonstrable critical failure — blocks the verdict from passing.
2.
HIGHstatistics
Recompute and correct the reported p-values for the primary effectiveness and safety non-inferiority endpoints in the Results and Abstract; the recomputed values (P=0.076 and P=0.809) are inconsistent with the reported P<0.0001.
Two demonstrable p-value errors undermine the primary non-inferiority claims and require correction or clarification to avoid misleading readers.
3.
HIGHrigor
Clarify whether the reported non-inferiority p-values are actually for the Farrington-Manning test or for a different comparison; if the recomputed values are correct, the non-inferiority conclusion may not hold and the paper's headline claim must be revised.
The inconsistency between reported and recomputed p-values raises the possibility that the non-inferiority conclusion is not supported by the data.
4.
HIGHdata code
Complete the data availability statement in the Data availability section by specifying the supplementary information or repository link, and provide a concrete access route (e.g., managed-access platform or data access committee) for source data.
The current statement is incomplete and vague, failing to meet transparency standards for a clinical trial.
5.
HIGHreporting
Explicitly state adherence to the CONSORT reporting guideline in the Methods or provide a completed CONSORT checklist as supplementary material.
Explicit reporting guideline adherence strengthens transparency and reproducibility.
6.
MEDIUMreporting
Add a note in the Discussion about the generalizability of findings given the predominantly White/Caucasian cohort (93.9-95.7%).
The lack of diversity may limit generalizability, and acknowledging this is important for readers.
7.
MEDIUMreporting
Clarify the handling of missing data for the primary effectiveness analysis (e.g., sensitivity analyses) in the Methods.
The exclusion of 2 investigational and 6 control patients from the effectiveness analysis but not the safety analysis should be explicitly justified.
8.
MEDIUMreporting
Provide a CONSORT flow diagram with more detailed reasons for exclusions and dropouts, and clarify the discrepancy between 469 enrolled and 432 randomized in the abstract.
The large drop from enrollment to randomization may confuse readers; a detailed flow diagram improves transparency.
9.
MEDIUMreporting
State whether any deviations from the pre-specified statistical analysis plan occurred, and if so, describe them.
Transparency about protocol deviations is essential for clinical trial reporting.
10.
MEDIUMreporting
Provide more detail on the blinding of outcome assessors and core laboratories in the Methods.
Clarifying who was blinded beyond patients strengthens the description of blinding.
11.
LOWcopyedit
Fix the incomplete sentence in the Data availability section: 'All supporting data are available within the article and the .' by completing it with the specific supplementary information or repository.
The sentence is grammatically incomplete and should be corrected for clarity.
12.
LOWcopyedit
Remove the extra commas in the Methods, Interventions section: 'delivered for 4 s ,, .'
Extra punctuation is a minor copyedit issue that should be cleaned up.
13.
LOWcopyedit
Rephrase the sentence in the Discussion: 'The observed difference between the investigational and control arms was not driven by lower performance of the control arm.' for clarity.
The sentence is slightly awkward and could be clearer.

Full text (72,781 chars)Analyzed: Aug 16, 2026