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Catheter Ablation for AF in Patients With Severe Mitral Regurgitation After Successful Transcatheter Mitral-Valve Repair
Sponsor: Atrial Fibrillation Network
Summary
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 Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
956
Start Date
2026-07-01
Completion Date
2032-01-31
Last Updated
2026-02-02
Healthy Volunteers
No
Interventions
Usual Care
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
Patients randomised to AF ablation will undergo pulmonary vein isolation using a safe and effective technology within 30 days after randomisation.
Locations (4)
University Hospital Cologne
Cologne, Germany
University Heart and Vascular Center Frankfurt
Frankfurt, Germany
Asklepios Hospital St. Georg
Hamburg, Germany
University Hospital Münster
Münster, Germany