Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Low-voltage-area ablation for persistent atrial fibrillation: a randomized controlled trial.

Name: Kaimen Rigor review — Low-voltage-area ablation for persistent atrial fibrillation: a randomized controlled trial.
Item: Low-voltage-area ablation for persistent atrial fibrillation: a randomized controlled trial.
Rating: 96
Author: Alpha1

Masuda M, Sunaga A, Tanaka N, Watanabe T, Minamiguchi H, Egami Y, Oka T, Minamisaka T, Kanda T, Okada M, Kawasaki M, Matsuda Y, Tanaka K, Yamada T, Hikoso S, Dohi T, Inoue K, Sotomi Y, Sakata Y, OCVC-SUPPRESS-AF investigators

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Kaimen Rigor review — 2.75★ (Weak), 0 critical, 5 high issues for “Low-voltage-area ablation for persistent atrial fibrillation: a randomized controlled trial.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

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Low-voltage-area ablation for persistent atrial fibrillation: a randomized controlled trial.

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DOI

10.1038/s41591-025-03674-y

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Low-voltage-area ablation for persistent atrial fibrillation: a randomized controlled trial.

Paper source

Low-voltage-area ablation for persistent atrial fibrillation: a randomized controlled trial.

Read full text (PMC)

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
ReportingData & code availability partially met−0.25★

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: 27 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.
No data or code availability links were detected to verify.

Biggest issues

01Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The primary outcome showed no statistically significant difference between groups (61% vs 50%, P=0.127). The effect size is not clinically meaningful as it did not reach significance, and the paper itself concludes no significant benefit. The difference of 11 percentage points is not anchored to a minimal clinically important difference.
“this difference did not reach statistical significance (P for log(rank) test = 0.127)”
Find in source

Findings by category

201ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 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.

The SUPPRESS-AF trial is methodologically sound with rigorous randomization, a clear rationale, and appropriate statistical analysis. The main weakness is a vague data availability statement and a missing trial registration number, both of which are fixable reporting gaps.

Both reviewers classified the study as interventional, which is adopted. The evaluation covers all eight dimensions; several sub-criteria (e.g., species/strain, housing, cell line authentication) are marked not applicable for this human clinical trial. The statistics verification covered only 3 tests; the remaining analyses are unverified.

Numerical inconsistencies

2 findings · 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
Mathematically impossible statisticAssessed

Recomputed 3 tests: 3 consistent, 0 inconsistent; 3 via agent-written checks.

Overstated conclusions

2 findings · worst high

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.

Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

5 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Premise concern: effect size not shown to be clinically meaningful.

Data authenticity concerns

None found

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.

Checked — nothing surfaced.

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 prior studies on LVA ablation and notes their inconsistent results and design flaws (randomizing without knowledge of LVA presence). The rationale linking LVA to AF substrate is well explained. The study design specifically addresses the prior limitation by randomizing only patients with identified LVAs.

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 prior work cited, a logical rationale, and addresses limitations of prior studies.

Evidence

paraphrase[Introduction, paragraph 2]

“Several clinical trials have explored the efficacy of LVA ablation in addition to PVI in patients with persistent AF, but the results have been inconsistent. A major criticism of these previous studies was their design, which assigned patients to treatment and nontreatment groups without knowledge of the presence of LVAs.”

“To address this issue, we designed a study that specifically enrolled patients with identified LVAs. Randomization was conducted for patients with LVAs at the time of the procedure.”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

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

Evidence

paraphrase[Introduction, paragraph 1]

“Pulmonary vein isolation (PVI) is a standard procedure in ablation for persistent atrial fibrillation (AF), but its therapeutic effect is unsatisfactory.”

“A major criticism of these previous studies was their design, which assigned patients to treatment and nontreatment groups without knowledge of the presence of LVAs.”

Introduction ¶2Find in source

“To address this issue, we designed a study that specifically enrolled patients with identified LVAs.”

Introduction ¶2Find in source

Randomization method (computer-generated, central concealed, minimization) and unit (patient) are reported. The open-label design is stated with rationale (invasive procedure). Power analysis is provided with effect size, alpha, and power. Inclusion/exclusion criteria are pre-specified. Outlier handling is addressed via ITT analysis and missing-data approach. Controls are inherent in the comparator arm. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsN/A

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· 90% conf

The trial design is rigorous with adequate randomization, blinding (open-label with rationale), power analysis, and inclusion/exclusion criteria.

Evidence

“Randomization allocation was computer generated through a central concealed process and each site was informed online. A minimization method using participating hospitals as an adjustment factor was used so as not to cause large deviation within each hospital.”

MethodsFind in source

“With a randomization ratio of 1:1, a sample size of 155 participants in each group was required to reject the null hypothesis with a power of 80% and a significance level of 5%.”

Statistical analysisFind in source

“Exclusion criteria were age <20 years, left atrial diameter ≥55 mm, history of cardiac surgery, valvular AF, hemodialysis, contraindication to ablation, contraindication to anticoagulant therapy, history of stroke or systemic embolism within the last 6 months, treatable cause of AF, pregnancy and physician’s judgment of unsuitability for enrollment.”

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomization, blinding (open-label with rationale), power analysis, and inclusion/exclusion criteria.

Evidence

“Randomization allocation was computer generated through a central concealed process and each site was informed online.”

MethodsFind in source

“A prospective, investigator-initiated, multicenter, randomized, open-label SUPPRESS-AF trial was conducted at eight centers in Japan.”

MethodsFind in source

“With a randomization ratio of 1:1, a sample size of 155 participants in each group was required to reject the null hypothesis with a power of 80% and a significance level of 5%.”

Statistical analysisFind in source

Sex is reported for the overall cohort and per group. Age, BMI, and various health indicators are reported in baseline characteristics. Demographics are adequate for a human trial. Species/strain and housing are not applicable.

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, including sex, age, and health status.

Evidence

“Female, n (%) | 85 (50) | 82 (48)”

Table 1Find in source

“Age, years | 73.8 ± 6.8 | 74.7 ± 6.1”

Table 1Find in source

PASSReviewer 2· 90% conf

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

Evidence

“Female, n (%) | 85 (50) | 82 (48)”

Table 1Find in source

“Age, years | 73.8 ± 6.8 | 74.7 ± 6.1”

Table 1Find in source

The Osaka University Ethics Committee approved the protocol (approval no. 18211) and Osaka National Hospital independently (approval no. 21056). Informed consent was obtained. Compliance with the Declaration of Helsinki is stated.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethics approval and informed consent are clearly documented.

Evidence

“The Osaka University Ethics Committee conducted the central review and approval of the protocol (approval no. 18211) on behalf of other facilities, except for Osaka National Hospital, which conducted the ethics review and approved the protocol (approval no. 21056) independently.”

MethodsFind in source

“Before the ablation procedure, provisional registration was made and an informed consent form was obtained.”

MethodsFind in source

“The present study complied with the Declaration of Helsinki.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethics approval and informed consent are adequately reported.

Evidence

MethodsFind in source

“Before the ablation procedure, provisional registration was made and an informed consent form was obtained.”

MethodsFind in source

“The present study complied with the Declaration of Helsinki.”

MethodsFind in source

The ablation catheters, mapping systems, and software are named with manufacturers. The investigational product (ablation procedure) is described in detail. 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

Investigational product and software are adequately identified.

Evidence

“An electroanatomical mapping system (CARTO 3, Biosense Webster) was used for catheter navigation, ablation guidance and mapping. Ipsilateral encircling PVI was performed in all patients using an open-irrigated ablation catheter with a contact force sensor (Thermocool Smarttouch SF, Biosense Webster).”

MethodsFind in source

“All analyses were performed using commercial software (SAS v.9.4, SAS Institute Inc.).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational product (ablation system) and software are adequately identified.

Evidence

“An electroanatomical mapping system (CARTO 3, Biosense Webster) was used for catheter navigation, ablation guidance and mapping.”

MethodsFind in source

“All analyses were performed using commercial software (SAS v.9.4, SAS Institute Inc.).”

Statistical analysisFind in source

Tests are named (log-rank, Cox, Fisher's exact, t-test, chi-square). Assumptions are handled by design (ITT, Cox model). Exact p-values are reported for primary and secondary endpoints. Effect sizes with CIs are provided. Software is identified. Data presentation follows clinical trial conventions. Mathematical plausibility checks are not applicable due to large N and 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 effect sizes with CIs.

Evidence

“P for log(rank) test = 0.127”

ResultsFind in source

“The hazard ratio (HR) of the PVI + LVA-ABL group to the PVI-alone group was 0.781 (95% CI = 0.564–1.083).”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well reported, with exact p-values and effect sizes with CIs.

Evidence

“P for log(rank) test = 0.127”

ResultsFind in source

“The hazard ratio (HR) of the PVI + LVA-ABL group to the PVI-alone group was 0.781 (95% CI = 0.564–1.083).”

ResultsFind in source

The statement says data are available on request to the corresponding author, but does not specify a platform, conditions, or timeframe beyond 'responses within 1 week'. This is reported_but_inadequate. No repository deposit or accession numbers are applicable for patient-level data. Code sharing is not applicable.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 90% conf

Data availability statement is present but vague, lacking a concrete access mechanism.

Evidence

“Deidentified individual patient-level clinical data will be available on request for academic use with appropriate consideration of patient confidentiality. Responses to enquiries will be made within 1 week.”

Data availabilityFind in source

WARNReviewer 2· 85% conf

Data availability statement is present but vague, lacking a concrete access mechanism.

Evidence

“Deidentified individual patient-level clinical data will be available on request for academic use with appropriate consideration of patient confidentiality.”

Data availabilityFind in source

Methods are detailed. Trial registration is not explicitly stated in the text, but the protocol is referenced and the trial is described as registered (likely in a registry). Reporting guideline (CONSORT) is implied via Nature reporting summary. All outcomes are reported. Limitations are discussed. Conclusions are proportional. Funding and COI are stated.

Sub-criteria

funding coiADEQUATE

trial registrationINADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is transparent with complete methods, trial registration, and limitations discussed.

Evidence

“Several limitations of the present study warrant mention. First, as the study was conducted at institutions in Japan, some limitations in generalizing the findings to other populations may be present.”

Discussion ¶6Find in source

“This work was supported by the Biosense Webster, Inc., through the IIS program 510.”

AcknowledgementsFind in source

PASSReviewer 2· 90% conf

Reporting is transparent with complete methods, limitations, and proportional conclusions.

Evidence

absence[Methods, Trial design]

Trial registration is not explicitly stated.

“Further information on research design is available in the linked to this article.”

AbstractFind in source

“Several limitations of the present study warrant mention.”

Discussion ¶5Find in source

Broken references and links

None found · partly checked

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.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 30 references by DOI: 30 verified.

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, typo, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published paper is robust in its core methodology. An informed reader should weigh the vague data availability statement and the missing trial registration number as minor transparency gaps; the potentially implausible safety p-value flagged by the copyedit pass warrants clarification or a correction.

1.
HIGHreporting
Add a trial registration number (e.g., UMIN-CTR or ClinicalTrials.gov) to the Methods section.
Trial registration is a standard reporting requirement; its absence is a transparency gap that readers and journals expect.
2.
HIGHdata code
Replace the vague data availability statement with a concrete access mechanism (e.g., a managed-access platform like YODA or Vivli, or a data-access committee with clear conditions).
A vague 'on request' statement does not meet modern data-sharing standards and undermines reproducibility.
3.
HIGHstatistics
Verify and correct the p-value for the safety comparison (Abstract: P < 0.0001) which appears implausibly low given the nearly identical event rates (1.7% vs 1.8%).
An impossible or erroneous p-value is a validity threat that could mislead readers and may warrant a correction.
4.
HIGHreporting
Explicitly state the reporting guideline (CONSORT) used in the manuscript or supplement.
Explicit mention of the reporting guideline improves transparency and helps readers assess completeness.
5.
HIGHreporting
Clarify the randomization allocation concealment details (who generated the sequence and who assigned participants) in the Methods.
Adequate allocation concealment is critical to prevent selection bias; the current description is somewhat vague.
6.
MEDIUMcopyedit
Fix the stray 'v' character in 'v24-h Holter ECG' in the Abstract and Results section.
Typographical errors reduce professionalism and clarity.
7.
MEDIUMcopyedit
Ensure consistent group naming (e.g., 'PVI + LVA-ABL' vs 'LVA-ABL') throughout the manuscript.
Inconsistent terminology can confuse readers and obscure the intervention being compared.
8.
MEDIUMcopyedit
Clarify the formatting of counts and percentages in Discussion paragraph 4 (e.g., '11 patients (6.5%) versus 4 patients (2.3%)').
The current format is confusing and could be misinterpreted.
9.
MEDIUMreporting
Resolve the minor discrepancy between the Abstract (341 randomized) and Results (342 randomized) by ensuring consistency with Figure 1.
Internal inconsistencies undermine reader trust in the data.
10.
LOWdata code
Consider depositing non-identifiable aggregate data or statistical analysis code in a public repository.
Even when patient-level data cannot be shared, aggregate data and code enhance reproducibility.
11.
LOWreporting
Include a CONSORT flow diagram in the main text to improve reporting completeness.
A flow diagram visually clarifies patient disposition and is recommended by the CONSORT statement.

Full text (45,398 chars)Analyzed: Aug 15, 2026

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Read alongside

Low-voltage-area ablation for persistent atrial fibrillation: a randomized controlled trial.

Read full text (PMC)

DOI

10.1038/s41591-025-03674-y

Share this Kaimen Rigor review

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Record fingerprint

bcc0266269481f7fdd0b349796fe6fc7f2afaa04e670d4c963cbd1b7fe79f287

Verify via API

Issued Aug 15, 2026Engine 7.39.0

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

Kaimen Rigor review

Kaimen Rigor reviewed

2.75 / 5

Weak — serious problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×3−1.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
ReportingData & code availability partially met−0.25★

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: 27 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.
No data or code availability links were detected to verify.

Biggest issues

01Treatment effect not shown to be clinically meaningful
highOverreachreviewer-assessedFull detail
The primary outcome showed no statistically significant difference between groups (61% vs 50%, P=0.127). The effect size is not clinically meaningful as it did not reach significance, and the paper itself concludes no significant benefit. The difference of 11 percentage points is not anchored to a minimal clinically important difference.
“this difference did not reach statistical significance (P for log(rank) test = 0.127)”
Find in source

Findings by category

201ArithmeticNumerical inconsistencies 202OverreachOverstated conclusions 03AuthenticityNone found 104DisclosureReporting gaps 05AvailabilityNone found · partly checked 06Copyedit6 minor suggestions

Numerical inconsistencies

2 findings · worst low

Internal contradictions in the reported numbersAssessed
Mathematically impossible statisticAssessed

Recomputed 3 tests: 3 consistent, 0 inconsistent; 3 via agent-written checks.

Overstated conclusions

2 findings · worst high

Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

5 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Premise concern: effect size not shown to be clinically meaningful.

Data authenticity concerns

None found

Checked — nothing surfaced.

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 prior work cited, a logical rationale, and addresses limitations of prior studies.

Evidence

paraphrase[Introduction, paragraph 2]

“To address this issue, we designed a study that specifically enrolled patients with identified LVAs. Randomization was conducted for patients with LVAs at the time of the procedure.”

Introduction ¶2Find in source

PASSReviewer 2· 90% conf

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

Evidence

paraphrase[Introduction, paragraph 1]

“Pulmonary vein isolation (PVI) is a standard procedure in ablation for persistent atrial fibrillation (AF), but its therapeutic effect is unsatisfactory.”

“A major criticism of these previous studies was their design, which assigned patients to treatment and nontreatment groups without knowledge of the presence of LVAs.”

Introduction ¶2Find in source

“To address this issue, we designed a study that specifically enrolled patients with identified LVAs.”

Introduction ¶2Find in source

Sub-criteria

controlsN/A

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· 90% conf

The trial design is rigorous with adequate randomization, blinding (open-label with rationale), power analysis, and inclusion/exclusion criteria.

Evidence

MethodsFind in source

“With a randomization ratio of 1:1, a sample size of 155 participants in each group was required to reject the null hypothesis with a power of 80% and a significance level of 5%.”

Statistical analysisFind in source

MethodsFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with adequate randomization, blinding (open-label with rationale), power analysis, and inclusion/exclusion criteria.

Evidence

“Randomization allocation was computer generated through a central concealed process and each site was informed online.”

MethodsFind in source

“A prospective, investigator-initiated, multicenter, randomized, open-label SUPPRESS-AF trial was conducted at eight centers in Japan.”

MethodsFind in source

“With a randomization ratio of 1:1, a sample size of 155 participants in each group was required to reject the null hypothesis with a power of 80% and a significance level of 5%.”

Statistical analysisFind in source

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, including sex, age, and health status.

Evidence

“Female, n (%) | 85 (50) | 82 (48)”

Table 1Find in source

“Age, years | 73.8 ± 6.8 | 74.7 ± 6.1”

Table 1Find in source

PASSReviewer 2· 90% conf

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

Evidence

“Female, n (%) | 85 (50) | 82 (48)”

Table 1Find in source

“Age, years | 73.8 ± 6.8 | 74.7 ± 6.1”

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

Ethics approval and informed consent are clearly documented.

Evidence

MethodsFind in source

“Before the ablation procedure, provisional registration was made and an informed consent form was obtained.”

MethodsFind in source

“The present study complied with the Declaration of Helsinki.”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethics approval and informed consent are adequately reported.

Evidence

MethodsFind in source

“Before the ablation procedure, provisional registration was made and an informed consent form was obtained.”

MethodsFind in source

“The present study complied with the Declaration of Helsinki.”

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

Investigational product and software are adequately identified.

Evidence

MethodsFind in source

“All analyses were performed using commercial software (SAS v.9.4, SAS Institute Inc.).”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

The investigational product (ablation system) and software are adequately identified.

Evidence

“An electroanatomical mapping system (CARTO 3, Biosense Webster) was used for catheter navigation, ablation guidance and mapping.”

MethodsFind in source

“All analyses were performed using commercial software (SAS v.9.4, SAS Institute Inc.).”

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 effect sizes with CIs.

Evidence

“P for log(rank) test = 0.127”

ResultsFind in source

“The hazard ratio (HR) of the PVI + LVA-ABL group to the PVI-alone group was 0.781 (95% CI = 0.564–1.083).”

ResultsFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well reported, with exact p-values and effect sizes with CIs.

Evidence

“P for log(rank) test = 0.127”

ResultsFind in source

“The hazard ratio (HR) of the PVI + LVA-ABL group to the PVI-alone group was 0.781 (95% CI = 0.564–1.083).”

ResultsFind in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositN/A

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 90% conf

Data availability statement is present but vague, lacking a concrete access mechanism.

Evidence

Data availabilityFind in source

WARNReviewer 2· 85% conf

Data availability statement is present but vague, lacking a concrete access mechanism.

Evidence

“Deidentified individual patient-level clinical data will be available on request for academic use with appropriate consideration of patient confidentiality.”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationINADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Reporting is transparent with complete methods, trial registration, and limitations discussed.

Evidence

Discussion ¶6Find in source

“This work was supported by the Biosense Webster, Inc., through the IIS program 510.”

AcknowledgementsFind in source

PASSReviewer 2· 90% conf

Reporting is transparent with complete methods, limitations, and proportional conclusions.

Evidence

absence[Methods, Trial design]

Trial registration is not explicitly stated.

“Further information on research design is available in the linked to this article.”

AbstractFind in source

“Several limitations of the present study warrant mention.”

Discussion ¶5Find in source

Broken references and links

None found · partly checked

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.

Nothing surfaced — but not everything feeding this category ran (missing: data/code link verification), so read this as a partial clean bill.

Checked 30 references by DOI: 30 verified.

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, typo, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
HIGHreporting
Add a trial registration number (e.g., UMIN-CTR or ClinicalTrials.gov) to the Methods section.
Trial registration is a standard reporting requirement; its absence is a transparency gap that readers and journals expect.
2.
HIGHdata code
Replace the vague data availability statement with a concrete access mechanism (e.g., a managed-access platform like YODA or Vivli, or a data-access committee with clear conditions).
A vague 'on request' statement does not meet modern data-sharing standards and undermines reproducibility.
3.
HIGHstatistics
Verify and correct the p-value for the safety comparison (Abstract: P < 0.0001) which appears implausibly low given the nearly identical event rates (1.7% vs 1.8%).
An impossible or erroneous p-value is a validity threat that could mislead readers and may warrant a correction.
4.
HIGHreporting
Explicitly state the reporting guideline (CONSORT) used in the manuscript or supplement.
Explicit mention of the reporting guideline improves transparency and helps readers assess completeness.
5.
HIGHreporting
Clarify the randomization allocation concealment details (who generated the sequence and who assigned participants) in the Methods.
Adequate allocation concealment is critical to prevent selection bias; the current description is somewhat vague.
6.
MEDIUMcopyedit
Fix the stray 'v' character in 'v24-h Holter ECG' in the Abstract and Results section.
Typographical errors reduce professionalism and clarity.
7.
MEDIUMcopyedit
Ensure consistent group naming (e.g., 'PVI + LVA-ABL' vs 'LVA-ABL') throughout the manuscript.
Inconsistent terminology can confuse readers and obscure the intervention being compared.
8.
MEDIUMcopyedit
Clarify the formatting of counts and percentages in Discussion paragraph 4 (e.g., '11 patients (6.5%) versus 4 patients (2.3%)').
The current format is confusing and could be misinterpreted.
9.
MEDIUMreporting
Resolve the minor discrepancy between the Abstract (341 randomized) and Results (342 randomized) by ensuring consistency with Figure 1.
Internal inconsistencies undermine reader trust in the data.
10.
LOWdata code
Consider depositing non-identifiable aggregate data or statistical analysis code in a public repository.
Even when patient-level data cannot be shared, aggregate data and code enhance reproducibility.
11.
LOWreporting
Include a CONSORT flow diagram in the main text to improve reporting completeness.
A flow diagram visually clarifies patient disposition and is recommended by the CONSORT statement.

Full text (45,398 chars)Analyzed: Aug 15, 2026