Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-25 @ 9:01 PM
Study NCT ID:
NCT04734756
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2021-06-11
First Post:
2021-01-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness Study of Dragonfly System for Degenerative Mitral Regurgitation
Sponsor:
Hangzhou Valgen Medtech Co., Ltd
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Objective Performance Criteria Study to Evaluate the Safety and Effectiveness of Dragonfly Transcatheter Mitral Valve Repair System for the Treatment of Degenerative Mitral Regurgitation (DMR) Subjects.
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of symptomatic moderate-to-severe(3+) or severe(4+) degenerative mitral regurgitation (DMR) in high surgical risk subjects.
Detailed Description:
This study is a prospective, multicenter, objective performance criteria design. Patients are clinically symptomatic patients with chronic moderate to severe (3+) or severe (4+) organic mitral regurgitation (DMR) who were assessed as high risk for surgical procedures by the cardiac team at the local clinical trial site. 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 the procedure, before discharge, and 30 days, 6 months, and 12 months after the procedure.
Treatment success at 12 months is used as the primary endpoint, with the definition as freedom from death, valve dysfunction surgery, and moderately severe or severe mitral regurgitation (MR \>2+) at 12 months.
The secondary endpoints include acute procedural success, acute device success, and surgery for valve dysfunction, NYHA class I or II at 30 days, 6 months, and 12 months, and the improvement in the quality of life change from baseline as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months after the procedure. The safety endpoints include major adverse events (MAEs), all-cause mortality, and cardiac mortality at 30 days, 6 months, and 12 months after the procedure.
To evaluate the safety and effectiveness of the Valgen Medtech DragonFly Transcatheter Mitral Valve Repair System in the treatment of patients with clinically significant chronic moderate (3+) or severe (4+) degenerative mitral regurgitation (DMR) who have been evaluated by the local heart team as being at high surgical risk, and to evaluate the product performance.
Treatment success at 12 months is used as the primary endpoint, with the definition as freedom from death, valve dysfunction surgery, and moderately severe or severe mitral regurgitation (MR \>2+) at 12 months.
The secondary endpoints include acute procedural success, acute device success, and surgery for valve dysfunction, NYHA class I or II at 30 days, 6 months, and 12 months, and the improvement in the quality of life change from baseline as assessed by the Kansas City Cardiomyopathy Questionnaire (KCCQ) score at 12 months after the procedure. The safety endpoints include major adverse events (MAEs), all-cause mortality, and cardiac mortality at 30 days, 6 months, and 12 months after the procedure.
To evaluate the safety and effectiveness of the Valgen Medtech DragonFly Transcatheter Mitral Valve Repair System in the treatment of patients with clinically significant chronic moderate (3+) or severe (4+) degenerative mitral regurgitation (DMR) who have been evaluated by the local heart team as being at high surgical risk, and to evaluate the product performance.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: