Actively Recruiting
DragonFly EU Pivotal Study
Led by Hangzhou Valgen Medtech Co., Ltd · Updated on 2025-11-24
168
Participants Needed
1
Research Sites
278 weeks
Total Duration
On this page
Sponsors
H
Hangzhou Valgen Medtech Co., Ltd
Lead Sponsor
D
Donawa Lifescience
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DragonFly EU Pivotal Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years old or older
- New York Heart Association (NYHA) Class II-IV
- Moderate to severe (3+) or severe (4+) chronic degenerative mitral regurgitation (DMR) for DMR cohort
- Symptomatic functional mitral regurgitation (FMR) grade 3+ or higher due to ischemic or non-ischemic cardiomyopathy for FMR cohort
- Transseptal catheterization and femoral vein access must be feasible
- Voluntarily agree to participate and sign informed consent form
You will not qualify if you...
- Echocardiographic evidence of intracardiac mass, thrombus, or vegetation
- Other severe heart valve diseases needing intervention
- Prior mitral valve leaflet surgery or previous transcatheter mitral valve intervention (prior annuloplasty ring allowed)
- Acute myocardial infarction within 4 weeks or untreated severe coronary artery stenosis requiring revascularization
- Cardiovascular intervention within 30 days or cardiac surgery within 6 months prior to procedure
- Femoral vein anatomy unsuitable for 25 F catheter or presence of inferior vena cava filter or ipsilateral deep vein thrombosis
- Contraindication to transesophageal echocardiogram (TEE) or general anesthesia
- End-stage heart failure (ACC/AHA stage D), heart transplant history, or waiting for transplant
- Active endocarditis, active rheumatic heart disease, or mitral valve changes due to these conditions
- Stroke within 30 days, severe carotid stenosis (>70%), carotid stent within 30 days, or hemorrhagic stroke within 6 months
- Acute peptic ulcer or gastrointestinal bleeding within 3 months
- Hemorrhagic disease, coagulation disorder, or contraindication to antithrombotic drugs
- Modified Rankin scale score 4 or higher
- Diseases complicating treatment evaluation such as cancer, severe metabolic disease, or psychosis
- Pregnant or lactating women
- Hemodynamic instability (systolic pressure <90 mmHg without afterload reduction medication), cardiogenic shock, or need for hemodynamic support devices
- Active infections requiring current antibiotics (temporary illness may be enrolled 2 weeks after antibiotics stop)
- Participation in another investigational drug or device study with incomplete primary endpoint or interfering with this study
- Poor compliance or judged unsuitable by investigator to complete the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Universitatsklinikum Bonn Medizinische Klinik und Poliklinik
Bonn, Germany
Actively Recruiting
Research Team
S
Shuangjie Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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