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Tests treatment safety and results for Tricuspid Regurgitation
Official title Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
ClinicalTrials.gov ID: NCT05556460
What this study is testing
What is Medical therapy?
Medical therapy is an investigational medicine, being studied as a potential treatment for tricuspid regurgitation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years
- In the judgment of the local cardiac team, the patient has been adequately treated according to applicable standards (including medical...
- Despite the drug optimization treatment according to the above method, patients still have symptoms of TR;
- Determined by the local cardiac team to be at intermediate or higher risk for tricuspid valve surgery
- New York Heart Association (NYHA) Cardiac function Class II-IVa; 5\. The patient is suitable for transcatheter tricuspid valve repair, suitable for...
You likely can't join if
- Tricuspid valve leaflet anatomy, which may preclude clip implantation, proper clip positioning on the leaflets, including but not limited to the...
- Evidence of calcification in the grasping area;
- Presence of a severe coaptation defect of the tricuspid leaflets;
- Severe leaflet defect(s) and cleft preventing proper device placement determined by ECL;
- Epstein anomaly.
- Other serious heart valvular diseases requiring intervention or planning to intervention in the next 12 months; Note: If mitral and tricuspid valve...
See the full eligibility criteria
- Age ≥ 18 years
- 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.
- Despite the drug optimization treatment according to the above method, patients still have symptoms of TR;
- Determined by the local cardiac team to be at intermediate or higher risk for tricuspid valve surgery
- 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...
- Tricuspid valve leaflet anatomy, which may preclude clip implantation, proper clip positioning on the leaflets, including but not limited to the following:
- Evidence of calcification in the grasping area;
- Presence of a severe coaptation defect of the tricuspid leaflets;
- Severe leaflet defect(s) and cleft preventing proper device placement determined by ECL;
- Epstein anomaly.
- 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...
- Tricuspid stenosis evaluated by ECL and/or cross-tricuspid differential pressure ≥ 5 mmHg;
- Previous tricuspid valve surgery or transcatheter therapy;
- Echocardiography suggested intracardiac thrombus, tumor or mass, or femoral vein and inferior vena cava implants or thrombus;
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chengdu, Sichuan, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.