DragonFly EU Pivotal Study
ConditionMitral Valve Insufficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHangzhou Valgen Medtech Co., Ltd
About this trial
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 in high surgical risk subjects and symptomatic moderate-to- severe (3+) or severe (4+) functional mitral regurgitation subjects who remained clinically symptomatic after adequate treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old
New York Heart Association (NYHA) Class II-IV
Moderate to severe (3+) or severe (4+) chronic DMR determined by transthoracic echocardiography (For DMR cohort)
Symptomatic FMR ≥ 3+ due to ischemic or non-ischemic cardiomyopathy (For FMR cohort)
Disqualifiers
Echocardiographic evidence of intracardiac mass, thrombus or vegetation
Other severe heart valve diseases requiring intervention
Prior mitral valve leaflet surgery (prior annuloplasty ring not excluded) or previous transcatheter mitral valve intervention
Acute myocardial infarction occurred within 4 weeks, or untreated severe coronary artery stenosis requiring revascularization
Trial design
Design model
Sequential
Treatments tested in this trial
DragonFly Transcatheter Mitral Valve Repair System
DeviceEdge-to-edge repair with DragonFly System
Treatment groups
168 Participants
are divided into 2 treatment groupsGroup A: DragonFly Transcatheter Mitral Valve Repair System-DMRExperimental treatment 1 intervention
Group B: DragonFly Transcatheter Mitral Valve Repair System-FMRExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Treatment success at 12 months after the procedure for DMR Cohort only
The rate of the composite endpoint of freedom from all-cause mortality, surgery for mitral valve dysfunction, or MR \> 2+ at 12 months.
Time frame
12 months2
Freedom from all-cause mortality, or hospitalization for heart failure events at 12 months after the procedure for FMR Cohort only
Freedom from all-cause mortality, or hospitalization for heart failure events at 12 months after the procedure for FMR Cohort only
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Hangzhou Valgen Medtech Co., Ltd
Lead sponsor
Donawa Lifescience
Collaborator
Source ClinicalTrials.gov