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

NCT07380932

Not Yet RecruitingNA

Sponsor: Atrial Fibrillation Network

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

Interventions: Usual Care, Pulmonary Vein Isolation

Countries: Germany

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).

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Patients with ECG-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.

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

Locations (4)

Cologne, Germany
Frankfurt, Germany
Hamburg, Germany
Münster, Germany