Catheter Ablation for AF in Patients With Severe Mitral Regurgitation After Successful Transcathe… (NCT07380932) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Composite of cardiovascular complications related to AF
Timeframe: Throughout study completion, estimated at a median follow-up period of 33 months.
2
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.