Heart valve repair showdown: flexible band vs rigid ring

NCT ID NCT04093297

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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

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

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • The First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210029, China

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