Evaluating the DragonFly-T System for Severe Tricuspid Regurgitation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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, Zhejiang University, School of Medicine
• Study coordinator: Bo Liu
• Email: bo.liu@valgenmed.com
• Phone: +8613001980902

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• 3D Echocardiography to See How CIEDs May Worsen Tricuspid Regurgitation

  This study tests whether different CIEDs (leadless pacemakers, LBBaP, and conventional pacemakers) differ in causing worsening tricuspid regurgitation, using 3D heart imaging.

  Recruiting Samsung Medical Center · Seoul, Seoul · NCT07793916

• Compare leadless and left bundle branch pacemakers for heart and valve function

  This study tests whether leadless pacemakers or left bundle branch area pacing better preserve heart and tricuspid valve function in adults needing a pacemaker.

  Recruiting Guy's and St Thomas' NHS Foundation Trust · London · NCT07534917

• TriClip for treating tricuspid regurgitation in Japan

  This study will see if the TriClip device is safe and helps people in Japan with symptomatic severe tricuspid regurgitation when used in routine clinical care.

  Recruiting Abbott Medical Devices · Suita, Osaka · NCT07509658

• Impact of transcatheter tricuspid valve repair on kidneys, strength, and activity in older adults

  This study will try catheter-based tricuspid valve repair (TEER) in older adults with severe symptomatic tricuspid regurgitation to see if kidney function, fluid overload, and physical activity improve.

  Recruiting Robert Bosch Medical Center · Stuttgart · NCT07464106

• TARGET 2.0: Cardiovalve TR replacement for tricuspid regurgitation

  This study will test a percutaneously delivered Cardiovalve tricuspid replacement via the femoral vein in adults with symptomatic severe secondary tricuspid regurgitation who are high risk for open-heart surgery.

  Recruiting Cardiovalve Ltd. · Bonn · NCT07334691

• Pivot Extend device to treat severe tricuspid regurgitation

  This trial will try the Pivot Extend device in adults with severe, symptomatic tricuspid regurgitation to see if it safely reduces valve leakage and improves symptoms.

  Recruiting Tau-MEDICAL Co., Ltd. · Macquarie Park, New South Wales · NCT07172477

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.