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

NCT07741253 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: 2026-3197
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Functional; Mitral Regurgitation (MR)

Keywords

Atrial functional mitral regurgitation; Transcatheter edge-to-edge repair; TEER; MitraClip; Guideline-directed medical therapy; High surgical risk; Secondary mitral regurgitation; Heart failure hospitalization

Outcome Measures

Primary Outcomes (2)

• 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.

  * 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.

  Within 12 months after randomization.

Secondary Outcomes (18)

• 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

  within 12 months after randomization

• Proportion of patients with MR ≤1+ at 30 days, 6 months, and 12 months

  30 days, 6 months, and 12 months

• Proportion of patients with MR ≤2+

  30 days, 6 months, and 12 months

• Residual MR grade and change from baseline

  30 days, 6 months, and 12 months

• Change in NYHA functional class and proportion of patients in NYHA class I/II

  30 days, 6 months, and 12 months

Study Arms (2)

TEER plus optimized GDMT group

EXPERIMENTAL

Device: Transcatheter Edge-to-Edge Repair

Optimized GDMT group

NO INTERVENTION

Interventions

Transcatheter Edge-to-Edge Repair DEVICE

Transcatheter 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.

TEER plus optimized GDMT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Aged ≥18 years;
• \. Presence of symptoms of heart failure, with New York Heart Association (NYHA) functional class II, III, or ambulatory class IV;
• \. 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+;
• \. 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;
• \. 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;
• \. 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;
• \. 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;
• \. The transseptal puncture route and femoral venous access are considered suitable for TEER by the investigator or Heart Team;
• \. 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.

You may not qualify if:

• \. 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;
• \. 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;
• \. Presence of pericardial disease, such as constrictive pericarditis, that may be the predominant mechanism underlying heart failure or MR;
• \. Prior surgical mitral valve intervention or transcatheter mitral valve intervention;
• \. Concomitant moderate-to-severe or greater disease of another heart valve requiring surgical or transcatheter intervention;
• \. An acute cerebrovascular event within the previous 30 days;
• \. 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;
• \. Severe symptomatic carotid artery stenosis, defined as \>70% stenosis on ultrasonography;
• \. Hemodynamic instability requiring continuous intravenous drug infusion or mechanical circulatory support;
• \. 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;
• \. 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;
• \. Chronic renal insufficiency requiring long-term hemodialysis;
• \. Severe liver cirrhosis accompanied by esophageal varices;
• \. Prior heart transplantation;
• \. Severe chronic obstructive pulmonary disease (COPD) requiring continuous home oxygen therapy or long-term oral glucocorticoid therapy;

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Chinese Academy of Medical Sciences, Fuwai Hospital: collaborator

Study Sites (1)

Fuwai Hospital

Beijing, China

Location

MeSH Terms

Conditions

Mitral Valve Insufficiency

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Zhinan Lu

CONTACT

+86 18600268732; lzn1982hy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The independent Clinical Events Committee will adjudicate major efficacy and safety events without knowledge of treatment assignment whenever feasible. Key echocardiographic assessments will be centrally reviewed by an independent echocardiography core laboratory using standardized procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to two parallel groups: TEER plus optimized guideline-directed medical therapy or optimized guideline-directed medical therapy alone. The study uses an open-label, blinded-endpoint (PROBE) design, with central blocked randomization stratified by study center or center group.

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

CN (1)