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

Starting soon · Not applicable

Conditions studied: Atrial Fibrillation (AF), Mitral Valve (MV) Regurgitation

In brief

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 facts

Study ID

NCT07380932

Run by

Atrial Fibrillation Network

People needed

956

Starts

2026-07-01

Expected to finish

2032-01-31

Last updated by the study team

2026-02-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with documented atrial fibrillation (AF).
• Transcatheter edge-to-edge mitral-valve repair (TEER) for severe functional mitral valve regurgitation (MR) with successful result (less than moderate MR, gradient < 5 mmHg) performed within a period of minimum of 30 days and a maximum of 6 months. Moderate residual MR is eligible if no further mitral valve intervention or surgery is planned and patient is stable for > 3 months.
• Provision of signed informed consent.

You may not qualify if…

• Age <18 years
• Patient not suitable for AF ablation
• Previous ablation procedure for AF
• Acute coronary syndrome, cardiac surgery, angioplasty, or cerebrovascular accident within 2 months prior to enrolment
• Untreated hypothyroidism or hyperthyroidism requiring therapy
• Enrolment in another randomised study
• Indication for cardiac resynchronization therapy
• Current pregnancy, breastfeeding, or women not using reliable contraceptive measures during fertility age
• Mental or physical inability to participate in the study
• Planned cardiovascular intervention or operation
• Life expectancy ≤ 12 month

Where it is running

• University Hospital Cologne — Cologne, Germany
• University Heart and Vascular Center Frankfurt — Frankfurt, Germany
• Asklepios Hospital St. Georg — Hamburg, Germany
• University Hospital Münster — Münster, Germany

Full record on ClinicalTrials.gov

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