Double heart fix: could adding valve repair to ablation beat ablation alone?
NCT ID NCT07744035
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This trial tests whether adding a minimally invasive mitral valve repair (transcatheter edge-to-edge repair, or TEER) to standard catheter ablation improves outcomes for people with both atrial functional mitral regurgitation and atrial fibrillation. Participants are randomly assigned to receive either ablation alone or ablation plus TEER during the same hospital stay. The study compares a combined measure of survival, heart-related hospitalizations, atrial fibrillation recurrence, and quality of life to see if the dual approach offers a meaningful advantage.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Transcatheter edge-to-edge repair (TEER) plus catheter ablation
- What this could lead to
- If successful, this combination approach could offer a more effective treatment strategy for people with both atrial functional mitral regurgitation and atrial fibrillation, potentially reducing hospitalizations and improving quality of life.
- What could go wrong
- The trial is randomized but not yet conclusive; the added procedure carries risks like bleeding or device complications, and the combination may not prove superior to ablation alone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 384 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years * Left ventricular ejection fraction ≥ 50% * Grading of MR: 3+ or 4+ (effective regurgitant orifice area≥30mm2, regurgitant volume ≥45ml) * Valve morphology: MR originating from the mid portion of the valve; mitral valve area\> 4 cm2; Length of posterior leaflet ≥10 mm; Sufficient leaflet tissue for mechanical coaptation: coaptation depth\< 11 mm, coaptation length\> 2 mm * Rate control in suspected AF-induced cardiomyopathy (heart rate \<80 bpm at rest and \<110 bpm during exercise) * Patients must be willing to comply with all follow-up requirements Exclusion Criteria: * Life expectancy\< 1 year due to non-cardiac conditions * Primary mitral regurgitation: valve abnormalities including leaflet tethering from LV dysfunction, intrinsic leaflet pathology (prolapse, flail, calcification, severe thickening), mitral annular calcification (either severe or \<severe but extending into the leaflets), and/or any mixed pathology * Active endocarditis of the mitral valve or rheumatic mitral valve disease * Hypotension (systolic pressure \< 90 mmHg) or requirement for inotropic support or mechanical hemodynamic support * Severe tricuspid regurgitation; Physical evidence of right-sided congestive heart failure with echocardiographic evidence of severe right ventricular dysfunction; Fixed pulmonary artery systolic pressure\> 70 mmHg * Stroke/TIA, TAVR, CRT/ CRT-D/ ICD, cardiac intervention or surgery within 30 days before randomization * Any prior MV surgery or transcatheter procedure * Need for any cardiac surgery (other than for MV disease) * Untreated clinically significant coronary artery disease * Echocardiographic evidence of intracardiac thrombus * Active infections requiring current antibiotic therapy * Patients who cannot tolerate anti-platelet/anticoagulation agents/contrast media * Pregnancy * Any condition making it unlikely the patient will be able to complete all protocol procedures (including compliance with medical therapy) and follow-up visits * Patient (or legal guardian) unable or unwilling to provide written informed consent before study enrollment
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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