An interventional study of Transcatheter edge to edge repair and Catheter ablation in Atrial Functional Mitral Regurgitation and Atrial Fibrillation (AF), sponsored by Mao Chen. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Mao Chen · Not applicable, Interventional, and Treatment
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.
Rationale:
The introduction of transcatheter edge-to-edge repair (TEER) for the treatment of functional mitral regurgitation (FMR) has led to a significant reduction in mortality and heart failure hospitalizations. However, the optimal timing and intervention for patients with atrial functional mitral regurgitation (AFMR) have not been evaluated in clinical trials. Published clinical trials, including COAPT, MITRA-FR, and RESHAPE-HF, did not classify functional mitral regurgitation according to ventricular or atrial origin. Concerns regarding the role of atrial fibrillation (AF) as a potential trigger of atrial dilatation and a consequence of atrial remodeling have led to recommendations for rhythm control in selected patients. Given the high incidence of AFMR among patients with persistent AF, successful ablation and maintenance of sinus rhythm may remain challenging. Therefore, concomitant TEER and catheter ablation are hypothesized to provide greater clinical benefit compared with catheter ablation alone.
Aim:
The purpose of this study is to evaluate the efficacy of TEER combined with catheter ablation in patients with significant AFMR and AF, focusing on clinical outcomes and atrial reverse remodeling.
Study design:
Patients with moderate-to-severe or severe AFMR and AF will be enrolled in a randomized, open-label, controlled study. Patients will be randomized in a 1:1 ratio to receive TEER combined with catheter ablation or catheter ablation alone. The study duration is anticipated to include 24 months of enrollment and 12 months of follow-up.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's planned enrollment of 384 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Mao Chen is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Patients will undergo catheter ablation and transcatheter edge to edge repair.
Device: Transcatheter edge to edge repair · Procedure: Catheter ablation
Patients will undergo catheter ablation only.
Procedure: Catheter ablation
Participants 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.
Also known as: TEER
Participants 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.
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 months
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 days
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 months
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 months
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 months
Heart failure hospitalizations
Heart failure hospitalization is defined as an unplanned admission lasting ≥24 hours due to acute decompensated heart failure, with symptoms, signs, and/or laboratory evidence of heart failure and requiring intravenous or mechanical heart failure therapies. Events will be identified through medical records and adjudicated according to predefined criteria.
Time frame: 12 months
Incidence of stroke or transient ischemic attack
Stroke and transient ischemic attack events will be identified through clinical assessment, medical records, and neuroimaging findings. Stroke will be classified as ischemic or hemorrhagic according to clinical diagnosis and imaging evaluation.
Time frame: 12 months
Change in left atrial volume index
Left atrial volume index is assessed by the biplane method of disks and indexed to body surface area.
Time frame: 12 months
Change in left atrial reservoir function from baseline
Left atrial reservoir function will be assessed using speckle-tracking echocardiography, and the change from baseline to 12 months will be evaluated.
Time frame: 12 months
Change in severity of tricuspid regurgitation from baseline
Tricuspid regurgitation severity will be assessed by transthoracic echocardiography using an integrated approach according to current guidelines. The change in tricuspid regurgitation severity from baseline to 12 months will be evaluated.
Time frame: 12 months
Change in NYHA functional classification from baseline
The New York Heart Association (NYHA) functional class will be assessed by clinical evaluation based on patients' symptoms and limitations during physical activity. The change from baseline to 12 months will be evaluated.
Time frame: 12 months
Change in N-terminal pro-B-type natriuretic peptide (NT-proBNP) level from baseline
Plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels will be measured using standard laboratory assays. The change from baseline to 12 months will be evaluated.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Mao Chen