CABA-MiTRA-AFNET 12-DZHK 34

Study design

An investigator-initiated, multicenter, prospective, randomized, open-label study with blinded endpoint assessment (PROBE design). This study investigates whether patients with atrial fibrillation are better protected against strokes and other serious complications after successful mitral valve repair through ablation than through standard treatment (Therapy Strategy Trial).

Inclusion Criteria

Patienten mit EKG-dokumentiertem Vorhofflimmern

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.

Informed, written consent.

Exclusion criteria

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