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

NCT07380932 | Not Yet Recruiting DMC

• 1 other identifier: CABA-MiTRA-AFNET12
• Study Type: interventional
• Target: 956
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Mitral Valve (MV) Regurgitation; Atrial Fibrillation (AF)

Keywords

Atrial fibrillation; Mitral valve regurgitation; Mitral valve repair; Catheter ablation

Outcome Measures

Primary Outcomes (2)

• Composite of cardiovascular complications related to AF

  It is defined as the time from randomisation to the first occurrence of (1) a composite of cardiovascular death, ischemic stroke or systemic embolic event,hospitalisation for heart failure (MACCE) and/or (2) death of any cause in a hierarchical order.

  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.

  Serious Adverse Events (SAEs), including primary and secondary outcome parameters if based on clinical events, will be adjudicated by the independent Clinical Event Committee (CEC) according to standardised definitions given in the CEC charter.

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

Secondary Outcomes (22)

• Time to individual components of first primary endpoint (MACCE)

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

• Time to ECG or ILR documented AF recurrence

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

• AF burden (ILR) assessed during the scheduled follow-up visits

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

• Heart failure progression (pro-BNP) at 3 and 12 months compared to baseline

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

• Heart failure progression (LV Function) at 3 and 12 months compared to baseline

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

Study Arms (2)

Usual Care

OTHER

Other: Usual Care

Pulmonary Vein Isolation

OTHER

Other: Pulmonary Vein Isolation

Interventions

Usual Care OTHER

Usual care will consist of optimal AF and heart failure therapy based on guideline recommendations and local protocols and usage. Individual treatment decisions will be taken by the site teams, considering the approved instruction for use (IFU) of medical devices and summary of product characteristics (SmPC) of all approved medications in patients with AF. The choice of therapies and medications follows routine care in line with medical guidelines and local policies at the discretion of the treating physician and should be based on the individual medical status of each study patient.

Usual Care

Pulmonary Vein Isolation OTHER

Patients randomised to AF ablation will undergo pulmonary vein isolation using a safe and effective technology within 30 days after randomisation.

Pulmonary Vein Isolation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Atrial Fibrillation Network: lead

Study Sites (4)

University Hospital Cologne

Cologne, Germany

Location

University Heart and Vascular Center Frankfurt

Frankfurt, Germany

Location

Asklepios Hospital St. Georg

Hamburg, Germany

Location

University Hospital Münster

Münster, 48149, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation; Gastroesophageal Reflux; Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Heart Valve Diseases

Study Officials

• Lars Eckardt, MD

  University Hospital Münster

  STUDY DIRECTOR

• Daniel Steven, MD

  University Hospital Cologne

  STUDY DIRECTOR

• Reza Wakili, MD

  University Heart and Vascular Center Frankfurt

  STUDY DIRECTOR

• Stephan Willems, MD

  Asklepios Hospital St. Georg

  STUDY DIRECTOR

Central Study Contacts

Vincent Beuger, PhD

CONTACT

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

Sabine Jürgensmeyer, PhD

CONTACT

+4925127600167; caba-mitra@af-net.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: blinded endpoint assessment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: February 2, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): January 31, 2032
• Last Updated: February 2, 2026

Record last verified: 2026-01

Locations

DE (4)