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PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk

RecruitingNAAges 18 Years - anyAllChina National Center for Cardiovascular Diseases
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In plain words

What the trial is, and whether it could suit you

Atrial functional mitral regurgitation (AFMR) develops when enlargement and remodeling of the left atrium and mitral annulus prevent the mitral valve leaflets from closing completely, allowing blood to leak backward through the valve. For patients with significant AFMR who remain symptomatic despite medical treatment and are at high risk for surgery, it is uncertain whether adding transcatheter mitral valve edge-to-edge repair (TEER), a catheter-based procedure that brings the mitral valve leaflets together, provides better outcomes than medical treatment alone. PRECISE-AFMR I is a prospective, multicenter, randomized study that will enroll 182 adults with moderate-to-severe or severe AFMR, high or prohibitive surgical risk, and mitral valve anatomy suitable for TEER. Participants will be assigned in a 1:1 ratio to receive TEER plus optimized guideline-directed medical therapy (GDMT) or

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📋 Eligibility rules (as published)
Inclusion Criteria: * 1\. Aged ≥18 years; 2\. Presence of symptoms of heart failure, with New York Heart Association (NYHA) functional class II, III, or ambulatory class IV; 3\. Confirmed by preliminary assessment of the study-site Heart Team and review by the Echocardiography Core Laboratory (ECL) to have at least moderate-to-severe atrial functional mitral regurgitation (AFMR), generally graded as 3+ or 4+; 4\. At least one hospitalization for heart failure within the 12 months prior to enrollment and/or a plasma B-type natriuretic peptide (BNP) level ≥300 pg/mL or N-terminal pro-B-type natriuretic peptide (NT-proBNP) level ≥1,500 pg/mL; 5\. As confirmed by a heart failure specialist at the study site, the subject has received maximally optimized guideline-directed medical therapy (GDMT) and other necessary standardized comprehensive treatment in accordance with current guidelines for at least 3 months. For subjects with concomitant atrial fibrillation, coronary artery disease, or other potentially correctable comorbidities, appropriate evaluation and guideline-recommended management must have been completed, or the subject must have been clearly determined to be unsuitable for further treatment; 6\. Determined by the multidisciplinary Heart Team, in accordance with the process described in Section 4.7, to be at high surgical risk, to have a contraindication to surgery, or to be unsuitable for surgery, or determined after comprehensive assessment that surgical treatment is not the optimal current strategy; 7\. During the screening period or within 90 days prior to randomization, mitral valve anatomy is assessed by echocardiography at the study site and confirmed by the ECL to be suitable for transcatheter edge-to-edge repair (TEER). Anatomical suitability must meet at least all of the following criteria: * Mitral valve area \>4.0 cm² and baseline mean transmitral pressure gradient \<4 mmHg; * Adequate mobility or sufficient graspable leaflet tissue in the target grasping area, with a mobile/graspable leaflet length ≥10 mm; * Mitral annular anteroposterior diameter ≤40 mm; * Left atrial volume index (LAVI) \<85 mL/m²; ⑤ Leaflet-to-annulus index (LAI) \>1.10; 8\. The transseptal puncture route and femoral venous access are considered suitable for TEER by the investigator or Heart Team; 9\. The subject or the subject's legally authorized representative voluntarily agrees to comply with the requirements of the study protocol, including the possibility of being randomized to the optimized GDMT group, and provides written informed consent. Exclusion Criteria: * 1\. Presence of primary structural mitral valve disease that can independently account for the mitral regurgitation (MR), such as leaflet prolapse, flail leaflet, rheumatic valvular disease, leaflet perforation, or damage resulting from infective endocarditis; 2\. Functional mitral regurgitation other than atrial functional mitral regurgitation (AFMR), including ventricular functional mitral regurgitation caused by left ventricular dilatation, regional wall-motion abnormalities, ischemic cardiomyopathy, dilated cardiomyopathy, or other conditions involving the myocardium, including restrictive cardiomyopathy, hypertrophic cardiomyopathy, and infiltrative cardiomyopathy such as amyloidosis, hemochromatosis, or sarcoidosis; 3\. Presence of pericardial disease, such as constrictive pericarditis, that may be the predominant mechanism underlying heart failure or MR; 4\. Prior surgical mitral valve intervention or transcatheter mitral valve intervention; 5\. Concomitant moderate-to-severe or greater disease of another heart valve requiring surgical or transcatheter intervention; 6\. An acute cerebrovascular event within the previous 30 days; 7\. Cardiovascular or cerebrovascular surgery or interventional treatment within the previous 30 days, including coronary artery bypass grafting (CABG), percutaneous coronary intervention (PCI), transcatheter aortic valve replacement (TAVR), or transcatheter carotid artery stenting; 8\. Severe symptomatic carotid artery stenosis, defined as \>70% stenosis on ultrasonography; 9\. Hemodynamic instability requiring continuous intravenous drug infusion or mechanical circulatory support; 10\. Pulmonary artery systolic pressure (PASP) \>70 mmHg as estimated by echocardiography, or pulmonary vascular resistance (PVR) \>3 Wood units as measured by right heart catheterization; 11\. Symptoms, signs, or echocardiographic evidence of severe right ventricular dysfunction, such as tricuspid annular plane systolic excursion (TAPSE) \<15 mm or peak systolic tissue Doppler velocity (S') \<10 cm/s; 12\. Chronic renal insufficiency requiring long-term hemodialysis; 13\. Severe liver cirrhosis accompanied by esophageal varices; 14\. Prior heart transplantation; 15\. Severe chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or long-term oral glucocorticoid therapy; 16\. Severe hematologic disease; 17\. A modified Rankin Scale score ≥4, indicating moderately severe or severe disability; 18\. Mitral valve anatomical features that, as assessed by echocardiography at the study site and confirmed by the Echocardiography Core Laboratory (ECL), may prevent safe implantation, appropriate positioning, stable leaflet grasping, or adequate reduction of MR with the transcatheter edge-to-edge repair (TEER) device. Such features include, but are not limited to, insufficient leaflet mobility or insufficient graspable leaflet tissue in the target grasping area, significant calcification in the grasping area, a prominent leaflet cleft, leaflet perforation, severe leaflet thickening, fibrosis, retraction, or severely restricted leaflet mobility, insufficient primary or secondary chordal support, or any other anatomical feature that, in the judgment of the ECL, may result in technic
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What it tests

  • Transcatheter Edge-to-Edge Repair
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Where

1 site
Fuwai Hospital
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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