Catheter Ablation for AF in Patients With Severe Mitral Regurgitation After Successful Transcatheter Mitral-Valve Repair

Sponsor
Atrial Fibrillation Network
Study ID
NCT07380932
Status
Not Yet Recruiting

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Conditions

  • Atrial Fibrillation (AF)
  • Mitral Valve (MV) Regurgitation

Eligibility Criteria

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

Interventions

  • Usual Care — OTHER
    Usual care will consist of optimal AF and heart failure therapy based on guideline recommendations and local protocols and usage. Individual treatment decisions will be taken by the site teams, considering the approved instruction for use (IFU) of medical devices and summary of product characteristics (SmPC) of all approved medications in patients with AF. The choice of therapies and medications follows routine care in line with medical guidelines and local policies at the discretion of the treating physician and should be based on the individual medical status of each study patient.
  • Pulmonary Vein Isolation — OTHER
    Patients randomised to AF ablation will undergo pulmonary vein isolation using a safe and effective technology within 30 days after randomisation.

Study Details

CABA-MiTRA-AFNET12 is a non-commercial, parallel-group, prospective, randomised, open, blinded endpoint assessment (PROBE), multi-centre, therapy strategy trial. The trial investigates patients with severe mitral valve regurgitation who have undergone transcatheter edge-to-edge mitral valve repair (M-TEER) and have concomitant atrial fibrillation (AF). The objective is to assess whether catheter ablation of AF is superior to standard-of-care treatment in patients after TEER in reduction of major adverse cardiovascular and cerebrovascular events (MACCE).

Key Dates

First listed
Feb 2, 2026
Start date
Jul 1, 2026
Status verified
Jan 2026
Primary completion
Jul 1, 2031
Completion
Jan 31, 2032

Study Design

Enrollment
956 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Other: Usual Care
  • Other: Pulmonary Vein Isolation

Primary Outcome Measure

Composite of cardiovascular complications related to AF [ Time Frame: Throughout study completion, estimated at a median follow-up period of 33 months. ]

Central Contacts

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