NCT04733404

Safety and Effectiveness Study of Dragonfly System for Functional Mitral Regurgitation

A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Safety and Effectiveness of Dragonfly Transcatheter Mitral Valve Repair System for the Treatment of Functional Mitral Regurgitation (FMR) Subjects.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hangzhou Valgen Medtech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To confirm the effectiveness and safety of the Dragonfly 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 design. Patients are chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment. After signing an informed consent form, subjects are enrolled and treated with the DragonFly Transcatheter Mitral Valve Repair System. All subjects receive clinical follow-up immediately after procedure, before discharge, 30 days after procedure, 6 months after procedure, and 12 months after procedure. The primary outcome is defined as a composite measure include all-cause mortality and recurrent heart failure hospitalization at 12 months after procedure. The secondary outcomes include acute procedural success, acute device success, mitral regurgitation degree (MR≤2+), recurrent heart failure hospitalization, NYHA class I or II at 30 days, 6 months, and 12 months, and the improvement in 6 minutes walk test distance, left ventricular end-diastolic volume, quality of life change as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score from baseline at 12 months after procedure. The safety endpoints include major adverse events (MAEs) at 30 days and 12 months after procedure, and all-cause mortality, cardiac mortality at 30 days, 6 months, and 12 months after procedure. To evaluate the safety and effectiveness of the Valgen Medtech DragonFly Transcatheter Mitral Valve Repair System in the treatment of patients with chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after guideline-directed medical treatment, and to evaluate the product performance.

Conditions

• Mitral Regurgitation Functional

Interventions

Type	Name	Description
DEVICE	Dragonfly Transcatheter Mitral Valve Repair System	To conduct edge-to-edge repair with Dragonfly System under the guidance of transesophageal echocardiography.

Timeline

• Start date: 2022-03-12
• Primary completion: 2023-09-30
• Completion: 2027-09-30
• First posted: 2021-02-02
• Last updated: 2022-03-29

Locations

1 site across 1 country: China