Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation (NCT07243158) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Randomized Controlled Study of Dragonfly System for Functional Mitral Regurgitation
China148 participantsStarted 2025-12-30
Plain-language summary
To confirm the effectiveness and safety of the Dragonfly transcatheter mitral valve repair system for the treatment of chronic moderate to severe (3+) or severe (4+) functional mitral regurgitation (FMR) who remained clinically symptomatic after adequate treatment.
Who can participate
Age range18 Years
SexALL
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:
1\) Age ≥ 18 yrs. 2) Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy
* 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:
1\) Echocardiographic evidence of intracardiac mass, thrombus, or vegetation. 2)Echocardiography revealed severe restriction of leaflet motion due to tethering.
3\) The presence of other severe heart valve disease requiring surgical intervention.
* Currently participating in an investigational drug or another device study that has not completed its primary endpoints or would clinically interfere with the endpoint of this study. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials.
* In the judgment of the investigator, subjects may not complete the trial according to poor compliance or in other circumstances when the investigator determines that the subject is unfit to participate in the study.