New heart valve clip could spare patients from Open-Heart surgery
NCT ID NCT05927441
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests the DragonFly device, a clip that repairs leaky mitral valves without open-heart surgery. It enrolls 168 people with moderate-to-severe mitral regurgitation who are too high-risk for surgery. The goal is to see if the device safely controls the leak and reduces heart failure symptoms over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DragonFly Transcatheter Mitral Valve Repair System (a device that clips the mitral valve to stop leakage)
- What this could lead to
- If successful, this device could offer a less invasive way to control mitral regurgitation and reduce heart failure symptoms without open-heart surgery.
- What could go wrong
- This is an early-stage study with no control group, so results may not prove superiority over existing treatments. Risks include procedural complications, device failure, or no improvement in heart function.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 168 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2024
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 catheterization and femoral vein access are determined to be feasible * Subjects have been informed of the nature of the study, understand the purpose of the clinical trial, voluntarily participate in the study, and sign the ICF Exclusion Criteria: * 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 * Any cardiovascular intervention within 30 days or cardiac surgery within 6 months prior to the procedure; or in the judgment of the investigator, the femoral vein cannot accommodate a 25 F catheter or the presence of an inferior vena cava filter would interfere with advancement of the catheter or ipsilateral deep vein thrombosis is present; or the patient's anatomy is not suitable for atrial septal puncture * Patients in whom TEE or general anesthesia is contraindicated * End stage heart failure (ACC/AHA stage D); or after heart transplantation; or waiting for a heart transplantation * Active endocarditis or active rheumatic heart disease; or mitral valve changes due to endocarditis and rheumatic heart valve disease * History of ischemia cerebrovascular accident in the past 30 days, or severe symptomatic carotid stenosis (ultrasonic examination showed stenosis degree \>70%); or carotid stent implantation within 30 days; hemorrhagic cerebrovascular accident occurred within 6 months * History of acute peptic ulcer or gastrointestinal bleeding within 3 months * Hemorrhagic disease or coagulation disorder; or contraindicated of antithrombotic drug treatment * Modified Rankin scale ≥ 4 * Diseases that make the evaluation of treatment difficult (e.g., cancer, severe metabolic disease, psychosis) * Pregnant or lactating women * Hemodynamic instability defined as systolic pressure \< 90 mmHg without afterload reduction medicine, or cardiogenic shock, or need for an intra-aortic balloon pump, or other hemodynamic support devices * Active infections requiring current antibiotic therapy (if temporary illness, patients may be enrolled 2 weeks after discontinuation of antibiotics) * Currently participating in an investigational drug or another device study of which the primary endpoint has not been completed, or it that clinically interferes with the current study endpoints. (Note: extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational study) * In the judgment of the investigator, the patients' compliance will be poor and could not complete the study as required, or other conditions indicate that the subject is not suitable to participate in the study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Universitatsklinikum Bonn Medizinische Klinik und Poliklinik
RECRUITINGBonn, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New heart valve implant offers hope for patients too sick for surgery
- Smaller incision, faster recovery? new study tests heart valve surgery approaches
- New heart valve procedure offers hope for High-Risk patients
- New heart valve technology put to the test in 777 patients