NCT07744035

Brief Summary

This trial is a randomized study for patients with significant atrial functional mitral regurgitation (AFMR) and atrial fibrillation (AF). The composite endpoint of all-cause mortality, cardiovascular-related hospitalizations, AF recurrence, and quality of life improvement is hypothesized to be superior with the combination of transcatheter edge-to-edge repair (TEER) and catheter ablation, compared with catheter ablation alone.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
384

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Sep 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
28 days until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

August 4, 2026

Status Verified

August 1, 2026

Enrollment Period

2 years

First QC Date

July 18, 2026

Last Update Submit

August 2, 2026

Conditions

Atrial Functional Mitral RegurgitationAtrial Fibrillation (AF)

Keywords

Transcatheter edge to edge repairCatheter ablation

Outcome Measures

Primary Outcomes (1)

  • Hierarchical Composite Clinical Endpoint (Win Ratio)

    The primary endpoint is a single hierarchical composite clinical endpoint analyzed by pairwise comparison. Each participant in the transcatheter edge-to-edge repair (TEER) plus catheter ablation group is compared with each participant in the catheter ablation alone group, in order of clinical priority: all-cause mortality, cumulative cardiovascular-related hospitalization, atrial fibrillation recurrence, and change in quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Each pairwise comparison is resolved at the highest-priority component that differs between the two participants, and results in a single "win," "loss," or "tie." The treatment effect is summarized as one win ratio, defined as the total number of wins divided by the total number of losses across all pairs, comparing the TEER plus catheter ablation group with the catheter ablation alone group.

    12 months

Secondary Outcomes (11)

  • Incidence of 30-day composite safety events

    30 days

  • Change in mitral regurgitation grade from baseline

    12 months

  • Composite of all-cause mortality and cardiovascular-related hospitalization

    12 months

  • Cardiovascular mortality

    12 months

  • Heart failure hospitalizations

    12 months

  • +6 more secondary outcomes

Study Arms (2)

TEER+Ablation

EXPERIMENTAL

Patients will undergo catheter ablation and transcatheter edge to edge repair.

Device: Transcatheter edge to edge repairProcedure: Catheter ablation

Catheter ablation

ACTIVE COMPARATOR

Patients will undergo catheter ablation only.

Procedure: Catheter ablation

Interventions

Transcatheter edge to edge repairDEVICE

Participants will undergo catheter ablation for persistent atrial fibrillation followed by transcatheter edge-to-edge repair (TEER) for the treatment of functional mitral regurgitation during the same hospitalization. TEER will be performed using an approved transcatheter mitral valve repair system to reduce mitral regurgitation severity and improve cardiac function.

Also known as: TEER
TEER+Ablation
Catheter ablationPROCEDURE

Participants will undergo catheter ablation for persistent atrial fibrillation during the study period. The procedure will include pulmonary vein isolation with additional ablation strategies as clinically indicated.

Catheter ablationTEER+Ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years
  • Left ventricular ejection fraction ≥ 50%
  • Grading of MR: 3+ or 4+ (effective regurgitant orifice area≥30mm2, regurgitant volume ≥45ml)
  • Valve morphology: MR originating from the mid portion of the valve; mitral valve area\> 4 cm2; Length of posterior leaflet ≥10 mm; Sufficient leaflet tissue for mechanical coaptation: coaptation depth\< 11 mm, coaptation length\> 2 mm
  • Rate control in suspected AF-induced cardiomyopathy (heart rate \<80 bpm at rest and \<110 bpm during exercise)
  • Patients must be willing to comply with all follow-up requirements

You may not qualify if:

  • Life expectancy\< 1 year due to non-cardiac conditions
  • Primary mitral regurgitation: valve abnormalities including leaflet tethering from LV dysfunction, intrinsic leaflet pathology (prolapse, flail, calcification, severe thickening), mitral annular calcification (either severe or \<severe but extending into the leaflets), and/or any mixed pathology
  • Active endocarditis of the mitral valve or rheumatic mitral valve disease
  • Hypotension (systolic pressure \< 90 mmHg) or requirement for inotropic support or mechanical hemodynamic support
  • Severe tricuspid regurgitation; Physical evidence of right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction; Fixed pulmonary artery systolic pressure\> 70 mmHg
  • Stroke/TIA, TAVR, CRT/ CRT-D/ ICD, cardiac intervention or surgery within 30 days before randomization
  • Any prior MV surgery or transcatheter procedure
  • Need for any cardiac surgery (other than for MV disease)
  • Untreated clinically significant coronary artery disease
  • Echocardiographic evidence of intracardiac thrombus
  • Active infections requiring current antibiotic therapy
  • Patients who cannot tolerate anti-platelet/anticoagulation agents/contrast media
  • Pregnancy
  • Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with medical therapy) and follow-up visits
  • Patient (or legal guardian) unable or unwilling to provide written informed consent before study enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Stone GW, Vahanian AS, Adams DH, Abraham WT, Borer JS, Bax JJ, Schofer J, Cutlip DE, Krucoff MW, Blackstone EH, Genereux P, Mack MJ, Siegel RJ, Grayburn PA, Enriquez-Sarano M, Lancellotti P, Filippatos G, Kappetein AP; Mitral Valve Academic Research Consortium (MVARC). Clinical trial design principles and endpoint definitions for transcatheter mitral valve repair and replacement: part 1: clinical trial design principles: A consensus document from the mitral valve academic research consortium. Eur Heart J. 2015 Aug 1;36(29):1851-77. doi: 10.1093/eurheartj/ehv281. Epub 2015 Jul 13.

    PMID: 26170467RESULT

  • Wunderlich NC, Siegel RJ. Peri-interventional echo assessment for the MitraClip procedure. Eur Heart J Cardiovasc Imaging. 2013 Oct;14(10):935-49. doi: 10.1093/ehjci/jet060.

    PMID: 24062377RESULT

  • Farhan S, Silbiger JJ, Halperin JL, Zhang L, Dukkipati SR, Vogel B, Kini A, Sharma S, Lerakis S. Pathophysiology, Echocardiographic Diagnosis, and Treatment of Atrial Functional Mitral Regurgitation: JACC State-of-the-Art Review. J Am Coll Cardiol. 2022 Dec 13;80(24):2314-2330. doi: 10.1016/j.jacc.2022.09.046.

    PMID: 36480974RESULT

  • Obadia JF, Messika-Zeitoun D, Leurent G, Iung B, Bonnet G, Piriou N, Lefevre T, Piot C, Rouleau F, Carrie D, Nejjari M, Ohlmann P, Leclercq F, Saint Etienne C, Teiger E, Leroux L, Karam N, Michel N, Gilard M, Donal E, Trochu JN, Cormier B, Armoiry X, Boutitie F, Maucort-Boulch D, Barnel C, Samson G, Guerin P, Vahanian A, Mewton N; MITRA-FR Investigators. Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation. N Engl J Med. 2018 Dec 13;379(24):2297-2306. doi: 10.1056/NEJMoa1805374. Epub 2018 Aug 27.

    PMID: 30145927RESULT

  • Stone GW, Abraham WT, Lindenfeld J, Kar S, Grayburn PA, Lim DS, Mishell JM, Whisenant B, Rinaldi M, Kapadia SR, Rajagopal V, Sarembock IJ, Brieke A, Marx SO, Cohen DJ, Asch FM, Mack MJ; COAPT Investigators. Five-Year Follow-up after Transcatheter Repair of Secondary Mitral Regurgitation. N Engl J Med. 2023 Jun 1;388(22):2037-2048. doi: 10.1056/NEJMoa2300213. Epub 2023 Mar 5.

    PMID: 36876756RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Radiofrequency AblationRadiofrequency TherapyTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Mao Chen

    West China Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhengang Zhao

CONTACT

86-18980733914zhaozhengang@foxmail.com

Lijun Zeng

CONTACT

86-18810672833zenglijun2019@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The experimental group will undergo transcatheter edge-to-edge repair plus catheter ablation, while the controlled group will undergo only catheter ablation.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Department of Cardiology

Study Record Dates

First Submitted

July 18, 2026

First Posted

August 4, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

September 1, 2029

Last Updated

August 4, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share