DragonFly EU Pivotal Study

Recruiting N/A Interventional Study
Mitral Valve Insufficiency
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
168 (estimated)
Sponsor
Hangzhou Valgen Medtech Co., Ltd · Industry
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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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * ≥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) * Transseptal…
Contacts

Shuangjie Li

+8617756106609

shuangjie.li@valgenmed.com

CONTACT