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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

NCT07741253 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2026-08-03

No results posted yet for this study

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)

Interventions

DEVICE

Transcatheter Edge-to-Edge Repair

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.

Sponsors & Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

    collaborator OTHER

  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07741253 on ClinicalTrials.gov