NCT07380932Not yet recruiting
Catheter Ablation for AF in Patients With Severe Mitral Regurgitation After Successful Transcatheter Mitral-Valve Repair
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 956 (estimated)
- First submitted
- 15 Jan 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 1 Sept 2031
- Lead sponsor
- Atrial Fibrillation Network
- Diseases
- Atrial fibrillation
- NCT number
- NCT07380932
What you commit to
- Study type: Interventional
- Planned participants: 956
- From 1 Sept 2026 to the primary completion date, 1 Sept 2031
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Indication for cardiac resynchronization therapy
Age
- Age \<18 years
- Current pregnancy, breastfeeding, or women not using reliable contraceptive measures during fertility age
Other
- Patient not suitable for AF ablation
- Enrolment in another randomised study
- Mental or physical inability to participate in the study
- Planned cardiovascular intervention or operation
- Life expectancy ≤ 12 month
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital Cologne Coordinator of this site? Confirm its status | Cologne | Germany | Unknown status |
| University Heart and Vascular Center Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Asklepios Hospital St. Georg Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
| University Hospital Munster Coordinator of this site? Confirm its status | Münster | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.