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 guideline-directed medical treatment.
Age ≥ 18 yrs.
Symptomatic functional mitral regurgitation (FMR) (≥3+) due to ischemic or non-ischemic cardiomyopathy Note 1: Functional MR requires the presence of overall or localized LV wall motion abnormalities that are considered to be the primary cause of MR. Despite the eligibility, subjects may not enroll if leaflet prolapse or other evidence of degenerative MR is present.
GDMT dose increase of no greater than 100% or decrease of no greater than 50%.
Coronary revascularization and/or implantation of a cardiac resynchronization therapy device (CRT or CRT-D) or reprogramming of the implanted CRT or CRT-D resulting in an increase in biventricular pacing (from <92% to ≥92%).
Echocardiographic evidence of intracardiac 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.
Hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis, infiltrative cardiomyopathy (e.g., amyloidosis, hemochromatosis, sarcoidosis, etc.), or any other structural heart disease causing heart failure other than dilated cardiomyopathy of either ischemic or non-ischemic etiology.
Single group
Dragonfly Transcatheter Mitral Valve Repair System
DeviceTo conduct edge-to-edge repair with Dragonfly System under the guidance of transesophageal echocardiography.
Number of patients with composite measures- All-cause death and recurrent HF hospitalizations.
A composite of all-cause death or recurrent heart failure (HF) hospitalizations.
Mitral regurgitation severity
Percentage of patients with mitral regurgitation of 2+ or less.
Recurrent heart failure (HF) hospitalizations
Number of patients with incidence of re-hospitalizations for heart failure after Dragonfly implantation.
NYHA Class
Number of patients with New York Heart Association (NYHA) Function Class I or II.
Change in 6 minutes walk test distance
Improvement in 6 Minute Walk Test distance at 12 months over baseline.
Incidence of major adverse events (MAEs)
MAE is defined as a combined clinical endpoint of death, stroke, myocardial infarction, renal failure, and nonelective cardiovascular surgery for device or procedure-related adverse events occurring after transseptal catheterization.
All-cause mortality
Percentage of all-cause death includes cardiac death, non-cardiac death, and death from unknown causes.
Cardiac mortality
Percentage of cardiac death
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