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.
1. Aged ≥18 years;
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;
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;
Parallel
Transcatheter Edge-to-Edge Repair
DeviceTranscatheter edge-to-edge repair (TEER) reduces mitral regurgitation by approximating the anterior and posterior mitral leaflets, increasing the leaflet coaptation area, and reducing the regurgitant orifice area.
Composite endpoint of all-cause mortality or hospitalization for heart failure within 12 months after randomization.
Composite endpoint of device-related major adverse events.
* Single leaflet device attachment (SLDA); * Device migration, device embolization, device detachment, or device fracture; * Device thrombosis; * Device-related infective endocarditis; * Mitral stenosis requiring surgical treatment or an unplanned repeat intervention; * Non-elective cardiac surgery or unplanned repeat mitral valve intervention due to a device-related complication; * Left ventricular assist device implantation; * Heart transplantation; * Other serious device-related complications adjudicated by the Clinical Events Committee (CEC) as device-related major adverse events in accordance with the Mitral Valve Academic Research Consortium (MVARC) criteria.
Hierarchical composite endpoint of all-cause mortality, hospitalization for heart failure, or urgent emergency department/outpatient intensification of heart failure therapy within 12 months after randomization
Proportion of patients with MR ≤1+ at 30 days, 6 months, and 12 months
Proportion of patients with MR ≤2+
Residual MR grade and change from baseline
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China National Center for Cardiovascular Diseases
Lead sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Collaborator
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