Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-26 @ 7:16 PM
Study NCT ID:
NCT05556460
Status:
RECRUITING
Last Update Posted:
2024-07-19
First Post:
2022-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
Sponsor:
Hangzhou Valgen Medtech Co., Ltd
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Parallel, Randomized Controlled Study to Evaluate the Safety and Effectiveness of the DragonFly-T Transcatheter Tricuspid Valve Clip System in the Treatment of Tricuspid Regurgitation
Status:
RECRUITING
Status Verified Date:
2024-07
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:
The primary objective of this trial is to demonstrate the safety and effectiveness of the DragonFly-T system in improving clinical outcomes in symptomatic patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery. This randomized controlled trial will compare the investigational device (DragonFly-T system) to Control (Medical Therapy).
Detailed Description:
A Prospective, Multicenter, Parallel, Randomized Controlled Study to Evaluate the Safety and Efficacy of the DragonFly-T Transcatheter Tricuspid Valve Clip System in the Treatment of Tricuspid Regurgitation. After signing the informed consent form, participants in the experimental group will be treated with the Dejin Medical DragonFly-T Transcatheter Tricuspid Valve Clip System and continue receiving medical therapy as determined by the investigator. Participants in the control group will continue to receive medical therapy as determined by the investigator. Control group participants are allowed to cross over to the experimental group after completing the 12-month follow-up. All participants will undergo clinical follow-up before discharge (not applicable to control group participants), at 30 days post-treatment, 6 months post-treatment, 12 months post-treatment, and annually at 2, 3, 4, and 5 years..
The primary endpoint is the hierarchical composite endpoint formed by all-cause mortality or tricuspid valve reintervention, heart failure hospitalization, and KCCQ improvement at 12 months post-treatment.
To evaluate the safety and effectiveness of the Valgen Medtech DragonFly-T Transcatheter Tricuspid Valve Repair System in the treatment of patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.
The primary endpoint is the hierarchical composite endpoint formed by all-cause mortality or tricuspid valve reintervention, heart failure hospitalization, and KCCQ improvement at 12 months post-treatment.
To evaluate the safety and effectiveness of the Valgen Medtech DragonFly-T Transcatheter Tricuspid Valve Repair System in the treatment of patients with severe tricuspid regurgitation (TR), who are at intermediate or greater estimated risk for mortality or morbidity with tricuspid valve surgery.
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?: