Safety and Effectiveness Study of Dragonfly System for Degenerative Mitral Regurgitation (NCT04734756) | Clinical Trial Compass
By InvitationNot Applicable
Safety and Effectiveness Study of Dragonfly System for Degenerative Mitral Regurgitation
China120 participantsStarted 2021-05-04
Plain-language summary
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of symptomatic moderate-to-severe(3+) or severe(4+) degenerative mitral regurgitation (DMR) in high surgical risk subjects.
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 yrs.
. Symptomatic moderate-to-severe (3+) or severe (4+) mitral valve regurgitation (DMR) confirmed by transthoracic echocardiography.
. NYHA functional class II, III, IV.
. Left ventricular ejection fraction (LVEF) ≥ 20%.
. Anatomically suitable for transcatheter mitral valve repair by edge-to-edge technique, and can be treated by the DragonflyTM device, as assessed by the site investigators and confirmed by the echo core laboratory and eligibility committee.
. High surgical risk as defined by either Society for Thoracic Surgery Risk Calculator score for valve replacement ≥ 8 points; or STS score for valve repair ≥ 6 points; or other high surgical risks. e.g. presence of ≥2 moderate to severe frailty factors; or the presence of possible surgical obstacles; or the presence of ≥2 major organ dysfunctions that could not be improved after surgery; or other surgical high-risk factors as determined by the local heart team.
. Transseptal catheterization and femoral vein access is determined to be feasible.
. The subject or subject's legal representative has been informed of the nature of the trial, willing to accept the experimental tests, and has provided written informed consent.
Exclusion criteria
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.
. Echocardiographic evidence of intra-cardiac mass, thrombus, or vegetation.
. The presence of other severe heart valve disease requiring surgical intervention.
. Prior mitral valve leaflet surgery or transcatheter mitral valve intervention.
. Estimated pulmonary artery systolic pressure (PASP) \> 70 mm Hg assessed by echocardiography.
. History of acute myocardial infarction in the prior 4 weeks or untreated clinically significant coronary artery disease requiring revascularization.
. Any percutaneous cardiac intervention within the 30 days, or any cardiac surgery within the 6 months prior to randomization; or if, in the judgment of the investigator, the subject's femoral vein is unable to accommodate a 25F catheter or has an ipsilateral deep venous thrombosis; or the anatomy is not accessible for transseptal puncture.
. Subjects in whom transesophageal echocardiography (TEE) or general anesthesia is contraindicated.
. End-stage heart failure (ACC/AHA stage D), or prior orthotopic heart transplantation, or on the waiting list for a heart transplantation.