NCT05556460

Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 236 (estimated)
• Sponsor: Hangzhou Valgen Medtech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tricuspid Regurgitation

Interventions

Type	Name	Description
DEVICE	DragonFly-T Transcatheter Tricuspid Valve Repair System	To conduct edge-to-edge repair with DragonFly-T System under the guidance of transesophageal echocardiography.
DRUG	Medical therapy	Subjects will continue to be managed on medical therapy, per physician discretion

Timeline

• Start date: 2024-08-15
• Primary completion: 2027-08-15
• Completion: 2027-12-15
• First posted: 2022-09-27
• Last updated: 2024-07-19

Locations

2 sites across 1 country: China