Evaluating the 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

This study is testing a new device to see if it can help people with severe tricuspid regurgitation feel better and avoid surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 236 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hangzhou Valgen Medtech Co., Ltd (Industry-sponsored)
• Locations: 2 sites (Chengdu, Sichuan and 1 other locations)
• Trial ID: NCT05556460 on ClinicalTrials.gov

What this trial studies

This trial aims to assess the safety and effectiveness of the DragonFly-T Transcatheter Tricuspid Valve Clip System in patients with severe tricuspid regurgitation who are at intermediate or higher risk for surgery. Participants will be randomly assigned to receive either the investigational device along with standard medical therapy or continue with medical therapy alone. The study will monitor clinical outcomes over a period of 12 months and beyond, focusing on mortality, heart failure hospitalizations, and quality of life improvements. The trial includes multiple follow-up assessments to evaluate long-term effects.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with symptomatic severe tricuspid regurgitation who are at intermediate or higher risk for surgery.

Not a fit: Patients with tricuspid valve anatomy unsuitable for clip implantation or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve clinical outcomes and quality of life for patients suffering from severe tricuspid regurgitation.

How similar studies have performed: While the specific DragonFly-T system is novel, similar transcatheter approaches for heart valve repair have shown promise in other studies.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years
2. In the judgment of the local cardiac team, the patient has been adequately treated according to applicable standards (including medical management)and has been stable for at least 30 days.
3. Despite the drug optimization treatment according to the above method, patients still have symptoms of TR;
4. Determined by the local cardiac team to be at intermediate or higher risk for tricuspid valve surgery
5. New York Heart Association (NYHA) Cardiac function Class II-IVa;

5\. The patient is suitable for transcatheter tricuspid valve repair, suitable for the use of this study instrument, and the femoral vein access is feasible and can accommodate catheter; 6. Patient must provide written informed consent before any steps related to the study.

Exclusion Criteria:

1. Tricuspid valve leaflet anatomy, which may preclude clip implantation, proper clip positioning on the leaflets, including but not limited to the following:

   1. Evidence of calcification in the grasping area;
   2. Presence of a severe coaptation defect of the tricuspid leaflets;
   3. Severe leaflet defect(s) and cleft preventing proper device placement determined by ECL;
   4. Epstein anomaly.
2. Other serious heart valvular diseases requiring intervention or planning to intervention in the next 12 months; Note: If mitral and tricuspid valve lesions are combined, mitral valve surgery can be performed first, and re-evaluation can be performed 60 days after surgery.
3. Tricuspid stenosis evaluated by ECL and/or cross-tricuspid differential pressure ≥ 5 mmHg;
4. Previous tricuspid valve surgery or transcatheter therapy;
5. Echocardiography suggested intracardiac thrombus, tumor or mass, or femoral vein and inferior vena cava implants or thrombus;
6. TTE and TEE are unable to evaluate tricuspid valve anatomy; Participated in any drug and/or medical device clinical trials within 1 month prior to the trial; ……

28\. The researchers do not consider it appropriate to be enrolled in the study.

Where this trial is running

Chengdu, Sichuan and 1 other locations

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Principal investigator: Jian'an Wang, MD, PH.D — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Bo Liu

Conditions Tricuspid Regurgitation