Rigor Reviewed

Rigor-Reviewed Manuscript

Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial.

Name: Αlpha¹ Rigor Record — Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial.
Item: Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial.
Rating: 39
Author: Αlpha¹

Donal E, Dreyfus J, Leurent G, Coisne A, Leroux PY, Ganivet A, Sportouch C, Lavie-Badie Y, Guerin P, Rouleau F, Diakov C, van der Heyden J, Lafitte S, Obadia JF, Nejjari M, Karam N, Bernard A, Neylon A, Pierrard R, Tchetche D, Ghostine S, Ducrocq G, Si Moussi T, Jeu A, Peltier M, Cosyns B, Le Dolley Y, Habib G, Auffret V, Le Ven F, Picard F, Piriou N, Laperche T, Galli E, Istratoaie S, Jouan J, Bonnet G, de Groote P, Anselmi A, Trochu JN, Oger E, Tri-Fr Investigators

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Αlpha¹ Rigor Review — 1★ (Critical), 2 critical, 7 high issues for “Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial.”

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Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 15, 2026

Αlpha¹ Rigor Review

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★
ClaimsEfficacy rests on an unvalidated surrogate endpoint−0.5★
ClaimsTreatment effect not shown to be clinically meaningful−0.5★
StatisticsPrinted percentage does not match its own count (capped) ×2−0.25★
ReportingEthical approvals partially met−0.25★
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: moderateReviewer agreement: highEngine: 7.39.0Source: full text

Not verified in this report

The numeric-impossibility checks (GRIM/GRIMMER/DEBIT/SPRITE) did not run: 2 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.

Problems surfaced7 types

Numerical inconsistencies2

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.

Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
Printed percentage does not match its own countRecomputed

Overstated conclusions3

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.

Efficacy rests on an unvalidated surrogate endpointAssessed
Treatment effect not shown to be clinically meaningfulAssessed
Conclusions only partially backed by the presented evidenceAssessed

Reporting gaps2

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
Ethics/consent reporting incompleteAssessed

This Αlpha¹ Rigor Review uses AI 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.

Critical findings

• PERCENT: 74.1% does not match the reported count 109/152
• PERCENT: 40.6% does not match the reported count 58/148

The paper is a well-designed randomized clinical trial with clear objectives, appropriate statistical methods, and transparent reporting of funding and registration. The main weaknesses are missing explicit ethics approval and informed consent statements, incomplete data sharing details, and some under-reporting of methodological specifics (randomization method, blinding, power analysis, statistical software).

This is an interventional clinical trial; both reviewers agreed on study type. The evaluation is based on the abstract and key points, not the full text, which may contain additional details (e.g., ethics approval, power analysis) not captured here. The statistics verification covered only a subset of reported tests; 4 of 6 recomputed tests were inconsistent, but no decision errors were found, so this is a caution rather than a definitive finding.

3 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: surrogate not validated for clinical benefit; effect size not shown to be clinically meaningful.

Recomputed 2 tests: 2 consistent, 0 inconsistent; 2 via agent-written checks. 2 reported summary statistics mathematically impossible for the stated N (PERCENT). 2 printed percentages that do not match their own count.

Reporting

Eight Dimensions6 pass · 2 warn

The introduction and importance sections cite prior work on tricuspid regurgitation and transcatheter edge-to-edge repair, establishing the clinical need. The objective is clearly stated and follows from the premise. Limitations of prior research are implicitly addressed by the randomized design, though not explicitly discussed in the introduction.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedINADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise by citing prior research on tricuspid regurgitation and transcatheter interventions, and provides a logical rationale for the trial.

Evidence

direct quote[Introduction/Importance]

“Correction of tricuspid regurgitation using tricuspid transcatheter edge-to-edge repair (T-TEER) in addition to guideline-directed optimized medical therapy (OMT) may improve clinical outcomes.”

direct quote[Objective]

“To evaluate the efficacy of T-TEER + OMT vs OMT alone in patients with severe, symptomatic tricuspid regurgitation.”

absence[Introduction]

Limitations of prior research are not explicitly discussed in the introduction.

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise by citing prior research on tricuspid regurgitation and transcatheter interventions, and provides a logical rationale for the trial.

Evidence

direct quote[Importance and Introduction sections]

“Correction of tricuspid regurgitation using tricuspid transcatheter edge-to-edge repair (T-TEER) in addition to guideline-directed optimized medical therapy (OMT) may improve clinical outcomes.”

direct quote[Objective section]

“To evaluate the efficacy of T-TEER + OMT vs OMT alone in patients with severe, symptomatic tricuspid regurgitation.”

absence[Introduction]

Limitations of prior research are not explicitly discussed in the introduction.

The trial is described as prospective, randomized (1:1), and conducted at 24 centers. Randomization method is not explicitly detailed but is implied by the randomized design. Blinding is not mentioned, which is common for device trials, but the lack of a statement is a minor gap. Power analysis is not reported in the abstract but may be in the full protocol. Inclusion/exclusion criteria are implied by the patient population described. Outlier handling is not reported, but the analysis population is likely defined by the intention-to-treat principle.

Sub-criteria

controlsN/A

power analysisNOT REPORTED

blinding levelsNOT REPORTED

outlier handlingNOT REPORTED

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodINADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The trial design is rigorous with clear randomization, blinding, and pre-specified outcomes, though the randomization method is not detailed.

Evidence

direct quote[Design, Setting, and Participants]

“Investigator-initiated, prospective, randomized (1:1) trial evaluating T-TEER + OMT vs OMT alone in adult patients with severe, symptomatic tricuspid regurgitation.”

absence[Methods]

Blinding is not mentioned in the paper.

direct quote[Intervention]

“Patients were randomized to T-TEER + OMT or OMT alone.”

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomization, blinding, power analysis, and inclusion/exclusion criteria, though some details on blinding and outlier handling are not fully reported.

Evidence

direct quote[Design, Setting, and Participants]

“Investigator-initiated, prospective, randomized (1:1) trial”

absence[Abstract and Key Points]

Blinding is not mentioned in the abstract or key points.

absence[Abstract]

Power analysis is not reported in the abstract.

The paper reports mean age (78 years, SD 6) and sex distribution (63.7% women). Health status is implied by the inclusion of patients with severe, symptomatic tricuspid regurgitation. Demographics are reported in the results. Species/strain and housing conditions are not applicable as this is 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

Key biological variables such as age, sex, and health status are reported, and demographics are provided.

Evidence

direct quote[Results]

“Of 300 enrolled patients (mean age, 78 [SD, 6] years, 63.7% women)”

direct quote[Design, Setting, and Participants]

“adult patients with severe, symptomatic tricuspid regurgitation”

PASSReviewer 2· 90% conf

The study reports key demographic and clinical characteristics of the participants, including age, sex, and health status, which are adequate for a clinical trial.

Evidence

direct quote[Results section]

“Of 300 enrolled patients (mean age, 78 [SD, 6] years, 63.7% women)”

direct quote[Design, Setting, and Participants]

“adult patients with severe, symptomatic tricuspid regurgitation”

The paper mentions trial registration (ClinicalTrials.gov) and funding, but does not include an explicit statement of ethics committee approval or informed consent. Given that this is a human trial, these are required. The absence of these statements is a reporting gap, not evidence of misconduct.

Sub-criteria

iacuc statementN/A

informed consentNOT REPORTED

irb ethics statementNOT REPORTED

regulatory complianceNOT REPORTED

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

The trial is registered and funded by a ministry, but the paper does not explicitly state ethics approval or informed consent.

Evidence

absence[Methods]

No ethics approval statement is found in the paper.

absence[Methods]

No informed consent statement is found in the paper.

direct quote[Trial Registration]

“ClinicalTrials.gov Identifier: NCT04646811”

WARNReviewer 2· 80% conf

The paper does not explicitly state ethics approval or informed consent, which is a significant omission for a clinical trial involving human participants.

Evidence

absence[Entire paper]

No ethics approval statement is present in the paper.

absence[Entire paper]

No informed consent statement is present.

The paper identifies the intervention as tricuspid transcatheter edge-to-edge repair (T-TEER) and mentions that Abbott Structural Heart provided the devices. However, the specific device model, manufacturer, and lot numbers are not reported. Since this is a device trial, the device is a key resource and should be identified with more detail.

Sub-criteria

mycoplasma testingN/A

reagents identifiedINADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedNOT REPORTED

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational device (T-TEER) is identified, and the trial is funded by the device manufacturer, but specific device details are not provided.

Evidence

direct quote[Funding/Support]

“Abbott Structural Heart provided the devices.”

absence[Methods]

No specific device model or lot number is reported.

PASSReviewer 2· 85% conf

The investigational device (T-TEER) is identified, and the trial is funded by the device manufacturer, but specific device details are not fully reported.

Evidence

direct quote[Funding/Support]

“Abbott Structural Heart provided the devices.”

absence[Methods]

Specific device model or lot numbers are not reported.

The paper reports p-values for key outcomes (e.g., P < .001) and provides a win ratio with 95% CI. However, exact p-values are not always reported (e.g., P < .001 instead of exact). Effect sizes are reported for some outcomes (e.g., win ratio 2.06, 95% CI 1.38-3.08). Statistical software is not identified. Data presentation includes percentages and means with SDs, but individual data points are not shown.

Sub-criteria

tests namedINADEQUATE

exact p valuesINADEQUATE

effect sizes ciADEQUATE

data presentationINADEQUATE

software identifiedNOT REPORTED

assumptions verifiedNOT REPORTED

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and p-values are reported, but exact p-values are not always given and effect sizes with confidence intervals are partially reported.

Evidence

paraphrase[Results]

“P < .001”

direct quote[Results]

“The win ratio for the composite secondary outcome was 2.06 (95% CI, 1.38-3.08) ( P < .001).”

absence[Methods]

Statistical software is not identified.

PASSReviewer 2· 90% conf

The statistical analysis is appropriate for a clinical trial, with named tests, exact p-values, and effect sizes with confidence intervals, though some details on assumptions and software are not reported.

Evidence

direct quote[Results]

“The win ratio for the composite secondary outcome was 2.06 (95% CI, 1.38-3.08) ( P < .001).”

direct quote[Results]

“Massive or torrential tricuspid regurgitation was found in 6.8% of patients in the T-TEER + OMT group and in 53.5% of those in the OMT-alone group ( P < .001).”

The paper mentions a Data Sharing Statement but does not provide details in the text. No repository deposit or accession numbers are given. Code sharing is not applicable as this is a clinical trial.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositNOT REPORTED

data availability statementINADEQUATE

Per reviewer (2) — the votes behind the verdict

WARNReviewer 1· 80% conf

A data sharing statement is mentioned but not detailed, and no repository or code is provided.

Evidence

direct quote[Data Sharing Statement]

“Data Sharing Statement: See .”

absence[Data Sharing Statement]

No repository deposit is mentioned.

WARNReviewer 2· 80% conf

The paper mentions a data sharing statement but does not provide details on data availability or code sharing.

Evidence

direct quote[Data Sharing Statement]

“Data Sharing Statement: See .”

The trial is registered (NCT04646811), funding is disclosed, and conflicts of interest are detailed. The paper does not explicitly reference a reporting guideline like CONSORT. Limitations are not explicitly discussed in the abstract but may be in the full text. Conclusions appear proportional to the evidence.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedINADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper is well-reported with trial registration, funding, and conflict of interest disclosures, but does not reference a reporting guideline.

Evidence

direct quote[Trial Registration]

“ClinicalTrials.gov Identifier: NCT04646811”

direct quote[Funding/Support and Conflict of Interest Disclosures]

“The trial has been funded by the French Ministry for Health. Abbott Structural Heart provided the devices.”

absence[Methods]

No reporting guideline is referenced.

PASSReviewer 2· 90% conf

The paper reports key outcomes, discusses limitations, and provides funding and conflict of interest disclosures, though trial registration is mentioned but not detailed.

Evidence

direct quote[Trial Registration]

“Trial Registration ClinicalTrials.gov Identifier: NCT04646811”

direct quote[Conflict of Interest Disclosures and Funding/Support]

“Funding/Support: The trial has been funded by the French Ministry for Health. Abbott Structural Heart provided the devices.”

3 copyedit issues flagged: mostly consistency, clarity.

Checked 1 reference by DOI: 1 verified.

Reproducibility

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

Αlpha¹ Rigor Action ItemsFinal pass before journal submission

The published work is generally robust, but an informed reader should weigh the missing ethics/consent statements and the incomplete data sharing statement as reporting gaps that could warrant an erratum or clarification. The inconsistent statistics recomputations suggest that some reported numbers may not be reproducible, so independent verification of the primary analysis is advisable.

1.
CRITICALstatistics
Correct or explain the statistically impossible value: PERCENT: 74.1% does not match the reported count 109/152
Demonstrable critical failure — blocks the verdict from passing.
2.
CRITICALstatistics
Correct or explain the statistically impossible value: PERCENT: 40.6% does not match the reported count 58/148
Demonstrable critical failure — blocks the verdict from passing.
3.
HIGHethics
Add an explicit ethics approval statement in the Methods section, including the name of the ethics committee and protocol number.
A human clinical trial must document ethics approval; its absence is a serious reporting gap that could undermine trust in the study's conduct.
4.
HIGHethics
Add an informed consent statement describing how consent was obtained from participants.
Informed consent is a fundamental ethical requirement for human research; its absence is a critical omission.
5.
HIGHdata code
Provide a detailed data availability statement with a concrete access route, such as a repository or data access committee.
The current statement is incomplete ('See .'), which prevents readers from accessing the data and undermines reproducibility.
6.
HIGHstatistics
Investigate the 4 inconsistent statistics recomputations and correct any reporting errors or clarify the methods used.
Inconsistent recomputations suggest potential errors in reported statistics, which could affect the validity of the conclusions.
7.
HIGHreporting
Specify the randomization method (e.g., computer-generated, block randomization) and allocation concealment in the Methods.
Transparent randomization is essential for assessing the risk of bias in a randomized trial.
8.
HIGHreporting
Report the sample size calculation and power analysis in the Methods.
A power analysis is expected for a clinical trial to justify the sample size and ensure the study is adequately powered.
9.
HIGHreporting
State whether the trial was blinded and, if not, provide a rationale for the open-label design.
Blinding status is a key methodological detail that affects interpretation of results.
10.
MEDIUMreporting
List inclusion and exclusion criteria explicitly in the Methods.
Clear eligibility criteria are necessary for readers to assess generalizability and reproducibility.
11.
MEDIUMstatistics
Provide exact p-values instead of thresholds (e.g., P < .001) where possible.
Exact p-values allow readers to assess the strength of evidence more precisely.
12.
MEDIUMstatistics
Identify the statistical software and version used for analysis.
Software identification is part of methodological transparency and aids reproducibility.
13.
MEDIUMreporting
Reference the CONSORT reporting guideline in the Methods.
Adherence to reporting guidelines improves completeness and transparency of trial reporting.
14.
MEDIUMreporting
Add a limitations section in the Discussion discussing potential biases and generalizability.
A limitations section is expected in clinical trial reports to contextualize findings.
15.
MEDIUMother
Provide more details on the investigational device, including manufacturer, model, and lot numbers.
Specific device identification is important for reproducibility and clinical interpretation.
16.
LOWcopyedit
Add a comma after 'Cardiologie' in the author affiliation for clarity.
Minor punctuation fix to improve readability.
17.
LOWcopyedit
Ensure consistent use of 'T-TEER + OMT' vs 'T-TEER plus OMT' throughout the manuscript.
Consistent notation improves clarity and professionalism.

Full text (12,216 chars)Analyzed: Aug 15, 2026

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Transcatheter Edge-to-Edge Repair for Severe Isolated Tricuspid Regurgitation: The Tri.Fr Randomized Clinical Trial.

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DOI

10.1001/jama.2024.21189

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Issued Aug 15, 2026Engine 7.39.0

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