Atrial Fibrillation (AF)NCT07380932
Catheter Ablation for AF in Patients With Severe Mitral Regurgitation After Successful Transcatheter Mitral-Valve Repair
A study testing Pulmonary Vein Isolation in people with Atrial Fibrillation (AF) and Mitral Valve (MV) Regurgitation, run by Atrial Fibrillation Network at 4 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Mitral Valve (MV) Regurgitation
- What is being tested?
- Pulmonary Vein Isolation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 956 participants
- Where
- 4 sitesGermany
- Study dates
- 1 Sep 2026to 31 Mar 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany4 sites
University Hospital Cologne
Cologne
Daniel Steven, MD, + 49 221 478 32396, caba-mitra@af-net.eu
University Heart and Vascular Center Frankfurt
Frankfurt
Reza Wakili, MD, +49 69 6301-5789, caba-mitra@af-net.eu
Asklepios Hospital St. Georg
Hamburg
Stephan Willems, MD, +49 40 181885-2050/2309, caba-mitra@af-net.eu
University Hospital Münster
Münster, 48149
Lars Eckardt, MD, +49 251 834 7637, caba-mitra@af-net.eu
About this study
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).
Read the detailed description
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.
- Being tested
- Usual Care, Pulmonary Vein Isolation
- Keywords
- Atrial fibrillation, Mitral valve regurgitation, Mitral valve repair, Catheter ablation
- Medical subject headings
- Atrial Fibrillation, Gastroesophageal Reflux, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
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 IsolationOther
Patients randomised to AF ablation will undergo pulmonary vein isolation using a safe and effective technology within 30 days after randomisation.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Other | Not described Receives: Other: Usual Care |
| Pulmonary Vein Isolation | Other | Not described Receives: Other: Pulmonary Vein Isolation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Secondary outcomes (25)
Time to individual components of first primary endpoint (MACCE)
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Time to ECG documented AF recurrence
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Time to ILR documented AF recurrence (AF burden sub-study)
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Time to any documented AF recurrence
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
AF burden assessed in the AF burden (ILR) sub-study
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Atrial arrhythmias assessed in the AF burden (ILR) sub-study
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Other arrhythmias assessed in the AF burden (ILR) sub-study
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Total number of ECG documented AF recurrences
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Quality of life changes at 12 and 24 months compared to baseline (assessed by KCCQ-12)
Measured: From Enrollment to month 24.
Quality of life changes at 12 and 24 months compared to baseline (assessed by AFEQT)
Measured: From Enrollment to month 24
Quality of life changes at 12 and 24 months compared to baseline (assessed by EQ-5D-5L)
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).
Measured: From Enrollment to month 24.
MoCA-test score changes at 12 months compared to baseline
Measured: From Enrollment to month 12
Heart failure progression (pro-BNP) at 12 months compared to baseline
Measured: From Enrollment to month 12.
Heart failure progression (NYHA) at 12 months compared to baseline
Measured: From Enrollment to month 12
ECHO: LA size assessed at 12 months, and if available at 24 months and further yearly FU visits as changes to baseline
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
ECHO: LA volume assessed at 12 months, and if available at 24 months and further yearly FU visits as changes to baseline
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
ECHO: LV size assessed at 12 months, and if available at 24 months and further yearly FU visits as changes to baseline
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
ECHO: LV function assessed at 12 months, and if available at 24 months and further yearly FU visits as changes to baseline
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
ECHO: MR grading assessed at 12 months, and if available at 24 months and further yearly FU visits as changes to baseline
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Time to AF progression (documented as clinically evaluated)
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Time to AF regression (documented as clinically evaluated)
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Number of required re-M-TEER procedures over the entire follow-up duration
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Number of total ablations procedures over the entire follow-up duration
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Number of nights spent in hospital (per year)
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Number of ablation procedures per patient (including the index ablation procedure in the early AF ablation group)
Measured: Throughout study completion, estimated at a median follow-up period of 33 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start1 Sep 2026 (estimated)
- Primary completion1 Sep 2031 (estimated)
- Study completion31 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 956 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atrial Fibrillation Network
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Eckardt, MD, Study director, University Hospital MünsterDaniel Steven, MD, Study director, University Hospital of CologneReza Wakili, MD, Study director, University Heart and Vascular Center FrankfurtStephan Willems, MD, Study director, Asklepios Hospital St. Georg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380932
- Sponsor's protocol ID
- CABA-MiTRA-AFNET12-DZHK34
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Catheter Ablation for AF in Patients With Severe Mitral Regurgitation After Successful Transcatheter Mitral-Valve Repair
- ClinicalTrials.gov ID
- NCT07380932
- Acronym / sponsor ID
- CABA-MiTRA-AFNET12-DZHK34
- Keywords
- Atrial fibrillation, Mitral valve regurgitation, Mitral valve repair, Catheter ablation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 956 participants (estimated)
- Lead sponsor
- Atrial Fibrillation NetworkUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 1 Sep 2031 (estimated)
- Study completion
- 31 Mar 2032 (estimated)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Other | Other: Usual Care |
| Pulmonary Vein Isolation | Other | Other: Pulmonary Vein Isolation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareUsual 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. | Other | Usual Care |
| Pulmonary Vein IsolationPatients randomised to AF ablation will undergo pulmonary vein isolation using a safe and effective technology within 30 days after randomisation. | Other | Pulmonary Vein Isolation |
Primary outcome
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.
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.
25 secondary outcomes
Time to individual components of first primary endpoint (MACCE)
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Time to ECG documented AF recurrence
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Time to ILR documented AF recurrence (AF burden sub-study)
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Time to any documented AF recurrence
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
AF burden assessed in the AF burden (ILR) sub-study
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Atrial arrhythmias assessed in the AF burden (ILR) sub-study
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Other arrhythmias assessed in the AF burden (ILR) sub-study
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Total number of ECG documented AF recurrences
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Quality of life changes at 12 and 24 months compared to baseline (assessed by KCCQ-12)
Time frame: From Enrollment to month 24.
Quality of life changes at 12 and 24 months compared to baseline (assessed by AFEQT)
Time frame: From Enrollment to month 24
Quality of life changes at 12 and 24 months compared to baseline (assessed by EQ-5D-5L)
Time frame: From Enrollment to month 24.
MoCA-test score changes at 12 months compared to baseline
Time frame: From Enrollment to month 12
Heart failure progression (pro-BNP) at 12 months compared to baseline
Time frame: From Enrollment to month 12.
Heart failure progression (NYHA) at 12 months compared to baseline
Time frame: From Enrollment to month 12
ECHO: LA size assessed at 12 months, and if available at 24 months and further yearly FU visits as changes to baseline
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
ECHO: LA volume assessed at 12 months, and if available at 24 months and further yearly FU visits as changes to baseline
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
ECHO: LV size assessed at 12 months, and if available at 24 months and further yearly FU visits as changes to baseline
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
ECHO: LV function assessed at 12 months, and if available at 24 months and further yearly FU visits as changes to baseline
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
ECHO: MR grading assessed at 12 months, and if available at 24 months and further yearly FU visits as changes to baseline
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Time to AF progression (documented as clinically evaluated)
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Time to AF regression (documented as clinically evaluated)
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Number of required re-M-TEER procedures over the entire follow-up duration
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Number of total ablations procedures over the entire follow-up duration
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Number of nights spent in hospital (per year)
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Number of ablation procedures per patient (including the index ablation procedure in the early AF ablation group)
Time frame: Throughout study completion, estimated at a median follow-up period of 33 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lars Eckardt, MD study director
University Hospital Münster
Daniel Steven, MD study director
University Hospital of Cologne
Reza Wakili, MD study director
University Heart and Vascular Center Frankfurt
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Vein Isolation in people with Atrial Fibrillation (AF) and Mitral Valve (MV) Regurgitation, run by Atrial Fibrillation Network at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincent Beuger, PhD (+49 251 276001 64, caba-mitra@af-net.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of cardiovascular complications related to AF (time frame: Throughout study completion, estimated at a median follow-up period of 33 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.