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NCT Number: NCT07380932

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

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).

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Key information

Conditions

Atrial Fibrillation (AF) Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heart Diseases Heart Valve Diseases Mitral Valve (MV) Regurgitation Mitral Valve Insufficiency Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Cologne, Cologne, Germany

Loading trial locations.

About this study

The occurrence of atrial fibrillation (AF) as the most frequent arrhythmia is associated with an increased risk of stroke, acute coronary syndrome, heart failure, and cardiovascular death. AF is often associated with mitral valve regurgitation (MR) which represents the most frequent valvular heart disease in an elderly population. Both entities are not only linked by a complex pathophysiologic interplay but also the incidence of both is expected to increase due to the demographic factors, aging and obesity.

AF is also a frequent comorbidity in patients with mitral valve regurgitation (MR) undergoing transcatheter edge-to-edge repair (TEER) with an incidence between 33-53% in randomized controlled trials. This is of particular clinical relevance due the complex and deleterious interaction between AF, MR, and left ventricular dysfunction. AF may pronounce left ventricular systolic dysfunction and enhance functional MR by mitral annulus dilatation (3). Current data has shown that AF contributes markedly to the course of functional MR and determines an unfavourable outcome. Catheter ablation (CA) for AF in the setting of congestive heart failure (CHF) has recently been demonstrated to be associated with a prognostic benefit in all stages of systolic left ventricular heart failure (heart failure with reduced ejection fraction, HFrEF). Although, the benefit of rhythm control in general, but also after surgical mitral valve repair (MVR) has been shown data in the setting of AF in TEER is sparse. In a recent multi-center observational cohort, the outcome of patients undergoing CA before or after TEER was investigated. As a proof of concept, it was shown that CA was associated with a prognostic benefit outweighing the negative influence of AF. Thus, the present study aims at investigating the prognostic relevance of CA following TEER in a randomized, prospective design.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Composite of cardiovascular complications related to AF

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

    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.

  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.

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

    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.

Secondary outcomes

  1. Time to individual components of first primary endpoint (MACCE)

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

  2. Time to ECG or ILR documented AF recurrence

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

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

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

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

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

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

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

  6. Heart failure progression (MR severity) at 3 and 12 months compared to baseline

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

  7. AF recurrence

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

  8. Time to all-cause death

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

  9. Time to cardiovascular death

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

  10. Quality of life changes at 3 and 12 months compared to baseline (assessed by KCCQ-12)

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

  11. Quality of life changes at 3 and 12 months compared to baseline (assessed by AFEQT)

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

  12. Quality of life changes at 3 and 12 months compared to baseline (assessed by EQ-5D-5L)

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

    Quality of life as assessed by the EuroQol Group 5-Dimension 5-Level questionnaire (EQ-5D-5L): The resulting score of the UK index ranges from 1 (for the best state) to - 0.285 (for the worst state).

    EQ5D- VAS: visual-analogue scale (0 worst to 100 best).

  13. Time to occurrence of atrial tachycardia(s) (ILR)

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

  14. ECHO: LA size assessed as changes to baseline

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

  15. ECHO: LA volume assessed as changes to baseline

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

  16. ECHO: LV function assessed as changes to baseline

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

  17. ECHO: MR grading assessed as changes to baseline

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

  18. Time to AF progression (defined as change from paroxysmal to persistent AF as documented in the ILR)

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

  19. Number of required of re-M-TEER procedures

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

  20. Number of total ablations procedures

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

  21. Number of nights spent in hospital (per year)

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

  22. Any ablation other than the index procedure in the therapy arm.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Sabine Jürgensmeyer, PhD

CONTACT

[email protected]

+4925127600167

Vincent Beuger, PhD

CONTACT

[email protected]

+49 251 276001 64

Sponsors and collaborators

Lead sponsor

Atrial Fibrillation Network

Other

Registry information

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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