NCT05508438

To Evaluate the Efficacy and Safety of the Transfemoral Mitral Valve Repair System in the Treatment of Patients With Moderately Severe and Severe Functional Mitral Regurgitation(FMR) Who Remained Clinically Symptomatic After Guideline-directed Medical Treatment

A Prospective, Multicenter, Objective Performance Criteria Clinical Study to Evaluate the Efficacy and Safety of the Transfemoral Mitral Valve Repair System in the Treatment of Patients With Moderately Severe and Severe Functional Mitral Regurgitation(FMR)

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Pan Xiangbin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To confirm the effectiveness and safety of the transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment.

Detailed description

This study is a prospective, multicenter, objective performance criteria clinical design.Patients are moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment. All subjects receive clinical follow-up immediately after procedure, before discharge, 30 days after procedure, 6 months after transfemoral mitral-valve repair, 12 months and 2 yeas，3 years，4 years after Transfemoral mitral-valve repair. The primary outcome is defined as all-cause death and rehospitalization due to heart failure 12 months after Transfemoral mitral-valve repair. The secondary outcomes include：Rate of rehospitalization due to heart failure after operation；Rate of postoperative mitral regurgitation (MR ≤ 2+)；Rate of New York Heart Association (NYHA) Function Class I or II after Transfemoral mitral-valve repair；Change in 6 minutes walk test distance；Improvement value of quality of life changes assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)；Echocardiographic changes in left ventricular end diastolic volume (LVEDV) from baseline；Acute procedural success，Acute device success.

Conditions

• Mitral Valve Insufficiency

Interventions

Type	Name	Description
DEVICE	Transfemoral mitral-valve repair	Transfemoral mitral-valve repair

Timeline

• Start date: 2022-08-30
• Primary completion: 2023-12-30
• Completion: 2027-12-30
• First posted: 2022-08-19
• Last updated: 2022-08-19

Locations

1 site across 1 country: China