New clip device aims to repair leaky heart valve without Open-Heart surgery
NCT ID NCT05556460
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new device called DragonFly-T that clips a leaky tricuspid heart valve closed, avoiding open-heart surgery. About 236 people with severe symptoms who are too high-risk for surgery will be randomly assigned to get the clip or continue medical therapy. The goal is to see if the device improves survival, reduces hospital stays, and boosts quality of life.
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 236 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2024
- Expected to finish
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Aug 2032
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.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years 2. In the judgment of the local cardiac team, the patient has been adequately treated according to applicable standards (including medical management)and has been stable for at least 30 days. 3. Despite the drug optimization treatment according to the above method, patients still have symptoms of TR; 4. Determined by the local cardiac team to be at intermediate or higher risk for tricuspid valve surgery 5. New York Heart Association (NYHA) Cardiac function Class II-IVa; 5\. The patient is suitable for transcatheter tricuspid valve repair, suitable for the use of this study instrument, and the femoral vein access is feasible and can accommodate catheter; 6. Patient must provide written informed consent before any steps related to the study. Exclusion Criteria: 1. Tricuspid valve leaflet anatomy, which may preclude clip implantation, proper clip positioning on the leaflets, including but not limited to the following: 1. Evidence of calcification in the grasping area; 2. Presence of a severe coaptation defect of the tricuspid leaflets; 3. Severe leaflet defect(s) and cleft preventing proper device placement determined by ECL; 4. Epstein anomaly. 2. Other serious heart valvular diseases requiring intervention or planning to intervention in the next 12 months; Note: If mitral and tricuspid valve lesions are combined, mitral valve surgery can be performed first, and re-evaluation can be performed 60 days after surgery. 3. Tricuspid stenosis evaluated by ECL and/or cross-tricuspid differential pressure ≥ 5 mmHg; 4. Previous tricuspid valve surgery or transcatheter therapy; 5. Echocardiography suggested intracardiac thrombus, tumor or mass, or femoral vein and inferior vena cava implants or thrombus; 6. TTE and TEE are unable to evaluate tricuspid valve anatomy; Participated in any drug and/or medical device clinical trials within 1 month prior to the trial; …… 28\. The researchers do not consider it appropriate to be enrolled 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
2 sites. 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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The Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITINGHangzhou, Zhejiang, 310000, China
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West China Hospital of Sichuan University
RECRUITINGChengdu, Sichuan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Lung and liver scans could map hidden heart valve disease
- Jugular vein approach tested for replacing leaky heart valve without open surgery
- Pacemaker showdown: which device spares the Heart's valve?
- Can a tiny heart implant fix a leaky valve without surgery?
- Can a catheter valve replace Open-Heart surgery for a leaky heart valve?
- A new Catheter-Based valve could fix a leaky heart valve without surgery