NCT05556460 Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
| NCT ID | NCT05556460 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hangzhou Valgen Medtech Co., Ltd |
| Condition | Tricuspid Regurgitation |
| Study Type | INTERVENTIONAL |
| Enrollment | 236 participants |
| Start Date | 2024-09-03 |
| Primary Completion | 2028-08-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 236 participants in total. It began in 2024-09-03 with a primary completion date of 2028-08-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Jian'an Wang, MD, PH.D
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital, School of Medicine, Zhejiang University
Frequently Asked Questions
Who can join the NCT05556460 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Tricuspid Regurgitation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05556460 currently recruiting?
Yes, NCT05556460 is actively recruiting participants. Contact the research team at bo.liu@valgenmed.com for enrollment information.
Where is the NCT05556460 trial being conducted?
This trial is being conducted at Chengdu, China, Hangzhou, China.
Who is sponsoring the NCT05556460 clinical trial?
NCT05556460 is sponsored by Hangzhou Valgen Medtech Co., Ltd. The principal investigator is Jian'an Wang, MD, PH.D at Second Affiliated Hospital, School of Medicine, Zhejiang University. The trial plans to enroll 236 participants.