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Life sciences · Interventional Study
ClinicalTrials.gov · October 26, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT07741253). This is a study registration, not published results. Lead sponsor: China National Center for Cardiovascular Diseases. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 182 participants (ESTIMATED). Conditions: Atrial Functional, Mitral Regurgitation (MR). Interventions: DEVICE: Transcatheter Edge-to-Edge Repair. Primary outcome measures: Composite endpoint of all-cause mortality or hospitalization for heart failure within 12 months after randomization. , Within 12 months after randomization.; Composite endpoint of device-related major adverse events. , Within 12 months after randomization.. Brief summary: 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 optimized GDMT alone. All participants will receive standardized medical care and will be followed for 12 months. The main effectiveness outcome is the occurrence of death from any cause or hospitalization for heart failure within 12 months. The main safety outcome is the occurrence of major device-related adverse events within 12 months. The study will also assess mitral regurgitation severity, symptoms, functional capacity, quality of life, heart failure events, and use of health care resources.