Ablation With Transcatheter Edge-to-edge Repair for Atrial Functional Mitral Regurgitation and Atrial Fibrillation

Sponsor
Mao Chen
Study ID
NCT07744035
Status
Not Yet Recruiting

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Conditions

  • Atrial Fibrillation (AF)
  • Atrial Functional Mitral Regurgitation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Transcatheter edge to edge repair — DEVICE
    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.
  • Catheter ablation — PROCEDURE
    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.

Study Details

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.

Key Dates

First listed
Aug 4, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Sep 1, 2028
Completion
Sep 1, 2029

Study Design

Enrollment
384 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TEER+Ablation
    Patients will undergo catheter ablation and transcatheter edge to edge repair.
  • Active Comparator: Catheter ablation
    Patients will undergo catheter ablation only.

Primary Outcome Measure

Hierarchical Composite Clinical Endpoint (Win Ratio) [ Time Frame: 12 months ]

Central Contacts

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