Not Yet RecruitingNot Applicable

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

Germany956 participantsStarted 2026-07-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. 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

What they're measuring

Composite of cardiovascular complications related to AF

Timeframe: Throughout study completion, estimated at a median follow-up period of 33 months.

The Primary Safety Outcomes are the occurrence of AF ablation associated serious adverse events, hemorrhagic stroke, and non-serious adverse events of special interest.

Timeframe: Throughout study completion, estimated at a median follow-up period of 33 months.

Trial details

NCT IDNCT07380932

SponsorAtrial Fibrillation Network

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2031-07-01

Contact for this trial

Vincent Beuger, PhD

+49 251 276001 64 caba-mitra@af-net.eu

View on ClinicalTrials.gov More Atrial Fibrillation (AF) trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Composite of cardiovascular complications related to AF

Timeframe: Throughout study completion, estimated at a median follow-up period of 33 months.

The Primary Safety Outcomes are the occurrence of AF ablation associated serious adverse events, hemorrhagic stroke, and non-serious adverse events of special interest.

Timeframe: Throughout study completion, estimated at a median follow-up period of 33 months.