Heart valve repair showdown: flexible band vs rigid ring
NCT ID NCT04093297
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two surgical techniques—flexible band and rigid ring—to repair a leaky tricuspid heart valve. About 300 adults with tricuspid regurgitation will be followed to see which method better prevents the need for repeat surgery, worsening of the leak, or death. The goal is to find the best long-term fix for this common heart condition.
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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 300 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 to 70 years
- 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: * 1\. Subject must be 18 years and 70 years at time of consent and must not be a member of a vulnerable population. * 2\. Subject or a legally authorized representative (where allowed per local regulations) must provide written informed consent prior to any trial related procedure. * 3\. Subjects with tricuspid regurgitation determined by the assessment of a qualifying transthoracic echocardiogram (TTE) and/or transesophageal echocardiogram (TEE). Exclusion Criteria: * 1\. Patient unable or unwilling to provide informed consent; * 2\. Subjects with mild tricuspid regurgitation; * 3\. Emergency surgery; * 4\. Prior tricuspid valve leaflet surgery or any currently implanted prosthetic tricuspid valve, or any prior transcatheter tricuspid valve procedure; * 5\. Subjects with percutaneous coronary intervention within prior 30 days prior to enrollment; * 6\. Subjects with presence of any known life threatening (non-cardiac major or progressive disease), non-cardiac disease that will limit the subject's life expectancy to less than one year; * 7\. Subjects with permanent or temporary pacemaker implantation; * 8\. Subjects with severe, irreversible pulmonary hypertension in the judgment of the investigator; * 9\. History of mitral/tricuspid endocarditis within the last 12 months; * 10\. Subjects with contraindication or known allergy to device's components, aspirin, anti-coagulation therapy or contrast media that cannot be adequately premeditated; * 11\. Subjects with bleeding or coagulation disorders (e.g. active peptic ulcer or active gastrointestinal bleeding); * 12\. Female patient is pregnant (urine HCG test result positive) or lactating; * 13\. Subject is currently participating in another clinical trial that has not yet completed its primary endpoint; * 14\. Subjects with left ventricular ejection fraction (LVEF)≤20%.
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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
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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 First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029, 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