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

Launched by HANGZHOU VALGEN MEDTECH CO., LTD · Sep 23, 2022

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ClinConnect Summary

The clinical trial titled "Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation" is investigating a new device called the DragonFly-T system. This trial aims to see if the DragonFly-T system is safe and effective for patients experiencing severe tricuspid regurgitation (TR), a condition where the heart's tricuspid valve doesn’t close properly, leading to symptoms like fatigue and swelling. The study will compare the outcomes of patients using the DragonFly-T system to those receiving standard medical therapy. It is currently recruiting participants who are at least 18 years old, have been stable after medical treatment for 30 days, and still have symptoms despite this treatment.

To participate, patients should be considered at intermediate or higher risk for surgery and have specific heart function levels. They will need to provide written consent before joining the trial. Participants can expect to undergo a procedure using the DragonFly-T system, along with regular check-ups to monitor their health throughout the study. It's important to note that certain heart conditions or previous surgeries may make someone ineligible for this trial, as determined by the local cardiac team. Overall, this study hopes to provide valuable insights into a potential new treatment for patients with this challenging heart condition.

Gender

ALL

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.