Ablation With Transcatheter Edge-to-edge Repair for Atrial Functional Mitral Regurgitation and Atrial Fibrillation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMao Chen
About this trial
This trial is a randomized study for patients with significant atrial functional mitral regurgitation (AFMR) and atrial fibrillation (AF). The composite endpoint of all-cause mortality, cardiovascular-related hospitalizations, AF recurrence, and quality of life improvement is hypothesized to be superior with the combination of transcatheter edge-to-edge repair (TEER) and catheter ablation, compared with catheter ablation alone.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Transcatheter edge to edge repair
DeviceParticipants will undergo catheter ablation for persistent atrial fibrillation followed by transcatheter edge-to-edge repair (TEER) for the treatment of functional mitral regurgitation during the same hospitalization. TEER will be performed using an approved transcatheter mitral valve repair system to reduce mitral regurgitation severity and improve cardiac function.
Catheter ablation
Procedure/SurgeryParticipants will undergo catheter ablation for persistent atrial fibrillation during the study period. The procedure will include pulmonary vein isolation with additional ablation strategies as clinically indicated.
Treatment groups
384 Participants
are divided into 2 treatment groupsGroup A: TEER+AblationExperimental treatment 2 interventions
Group B: Catheter ablationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hierarchical Composite Clinical Endpoint (Win Ratio)
The primary endpoint is a single hierarchical composite clinical endpoint analyzed by pairwise comparison. Each participant in the transcatheter edge-to-edge repair (TEER) plus catheter ablation group is compared with each participant in the catheter ablation alone group, in order of clinical priority: all-cause mortality, cumulative cardiovascular-related hospitalization, atrial fibrillation recurrence, and change in quality of life measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Each pairwise comparison is resolved at the highest-priority component that differs between the two participants, and results in a single "win," "loss," or "tie." The treatment effect is summarized as one win ratio, defined as the total number of wins divided by the total number of losses across all pairs, comparing the TEER plus catheter ablation group with the catheter ablation alone group.
Time frame
12 monthsSecondary outcomes
1
Incidence of 30-day composite safety events
The composite safety endpoint includes cardiovascular mortality, stroke, myocardial infarction, acute kidney injury, major bleeding, and non-elective cardiovascular surgery for device-related complications within 30 days after the procedure.
Time frame
30 days2
Change in mitral regurgitation grade from baseline
Mitral regurgitation severity will be assessed by transthoracic echocardiography according to an integrated approach recommended by current guidelines. The outcome will be the proportion of patients achieving mild or less mitral regurgitation (grade ≤2) at 12 months.
Time frame
12 months3
Composite of all-cause mortality and cardiovascular-related hospitalization
The composite endpoint includes all-cause mortality and cardiovascular-related hospitalization within 12 months. Death events will be identified through follow-up records, and cardiovascular-related hospitalizations will be confirmed by medical record review according to predefined criteria.
Time frame
12 months4
Cardiovascular mortality
Cardiovascular mortality is defined as death caused by cardiovascular causes and will be determined through review of medical records and clinical documentation.
Time frame
12 monthsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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