Hangzhou Valgen Medtech Co., Ltd
To confirm the effectiveness and safety of the DragonFly-T transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation (TR) (TR grade ≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment.
Tricuspid Regurgitation
DragonFly-T Transcatheter Tricuspid Valve Repair System
Not Applicable
This study is a prospective, multicenter, objective performance criteria design. Patients are severe TR (≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment. After signing an informed consent form, subjects are enrolled and treated with the DragonFly-T Transcatheter Tricuspid Valve Repair System. All subjects receive clinical follow-up immediately after the procedure, before discharge, 30 days after the procedure, 6 months after the procedure, 12 months, and 2, 3, 4, and 5 years after the procedure. The primary outcome is defined as a composite measure including all-cause mortality and recurrent heart failure hospitalization 12 months after the procedure. The secondary outcomes include acute procedural success, acute device success, the percentage of patients with tricuspid regurgitation of 2+ or less, the percentage of patients with tricuspid regurgitation reduced by at least one grade, the improvement in 6 minutes walk test distance, New York Heart Association (NYHA) class, quality of life change as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score and edema scale grading. To evaluate the safety and effectiveness of the Valgen Medtech DragonFly-T Transcatheter Tricuspid Valve Repair System in the treatment of patients with severe TR (≥ 3+) who remained clinically symptomatic after guideline-directed medical treatment,and to evaluate the product performance.}}
Study Type : | Interventional |
Estimated Enrollment : | 151 participants |
Masking : | None (Open Label) |
Primary Purpose : | Treatment |
Official Title : | A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Safety and Effectiveness of DragonFly-T Transcatheter Tricuspid Valve Repair System for the Treatment of Tricuspid Regurgitation Subjects |
Actual Study Start Date : | October 15, 2022 |
Estimated Primary Completion Date : | October 15, 2024 |
Estimated Study Completion Date : | October 15, 2028 |
Arm | Intervention/treatment |
---|---|
Experimental: DragonFly-T Tricuspid Valve Repair System The experimental group is allocated to use a novel tricuspid valve repair system for edge-to-edge repair manufactured by Hangzhou Valgen Medtech Co., Ltd. |
Device: DragonFly-T Transcatheter Tricuspid Valve Repair System |
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000