Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation (NCT05556460) | Clinical Trial Compass
RecruitingNot Applicable
Safety and Effectiveness Study of DragonFly-T System for Severe Tricuspid Regurgitation
China236 participantsStarted 2024-09-03
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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;
Exclusion criteria
. Tricuspid valve leaflet anatomy, which may preclude clip implantation, proper clip positioning on the leaflets, including but not limited to the following:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1The DragonFly-T system is being studied for severe tricuspid regurgitation — based on how severe my condition is right now, does my doctor think I'd be a reasonable candidate to discuss with the trial team?
2This trial is measuring a combination of outcomes including death, the need for further valve procedures, heart failure hospitalizations, and quality-of-life scores using something called the KCCQ — can my doctor explain what that quality-of-life measure is and how much improvement would be considered meaningful for someone in my situation?
3Since this is listed as 'Phase NA,' which often means it's a device feasibility or pivotal study rather than a traditional drug trial, what does my doctor know about how much safety and effectiveness data already exists for the DragonFly-T system specifically?
4Are there currently approved or standard treatments for severe tricuspid regurgitation — like medications, other minimally invasive procedures, or open surgery — that my doctor would recommend I try or at least consider before looking at an investigational device trial like this one?
5What would participating in this trial actually look like day-to-day — how many visits, how far would I need to travel, and how long would I be followed, so I can figure out whether that's realistic for my life right now?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Hierarchical Composite of All-cause Death or Tricuspid Valve Intervention, Heart Failure Hospitalizations, and KCCQ Improvement
. 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 re-evaluation can be performed 60 days after surgery.