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Heart lasso: new catheter belt tightens leaky valve without surgery

NCT ID NCT06479824

What the study statuses mean

This study's is highlighted.

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
Not open to general applications. Only people the study team invites can take part.
Paused This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This early study tests a new procedure called TRAIPTA for people with severe tricuspid valve regurgitation, a condition where a heart valve leaks and causes breathlessness and fluid buildup. The procedure uses a catheter to place a belt-like device around the heart from inside, tightening the valve to reduce leakage. The study will enroll 60 adults who cannot have standard surgery and will follow them for a year to check safety and heart function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
TRAIPTA device (a catheter-placed belt around the heart to tighten the leaky tricuspid valve)
What this could lead to
If it works, this could offer a less invasive option for people with severe tricuspid valve leakage who cannot have open-heart surgery.
What could go wrong
This is a very early feasibility study with only 60 participants, so it is not yet proven safe or effective. The procedure involves puncturing the heart and placing a permanent belt, which carries risks like bleeding, heart compression, or device-related complications.

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 60 people

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

Started

Aug 2025

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 100 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: * Adults \>= 21 years * Severe tricuspid valve regurgitation with intact tricuspid leaflets, due to annular dilation, leaflet tethering, etc. * NYHA class III or IV congestive heart failure (symptomatic tricuspid regurgitation) * Cardiac size suitable for available TRAIPTA study devices according to NHLBI Core Lab analysis of cardiac CTA indicating a TRAIPTA extracardiac perimeter of 25-40cm. * Concordance of the study central clinical eligibility committee * Consents to participate, in writing, and willing to comply with all study procedures for the duration of the study EXCLUSION CRITERIA: * Prior cardiac surgery, which may preclude pericardial access, or known pericardial adhesions * Prior coronary artery stent in the atrioventricular groove * Severe mitral valve regurgitation assessed by echo * Left ventricular systolic dysfunction, LVEF \< 0.30 * Right atrial pacemaker lead if it might preclude trans-atrial access for TRAIPTA * Eligible for commercially-available transcatheter tricuspid valve replacement * Eligible for commercially-available tricuspid edge-to-edge repair (TTEER). Recurrent or persistent symptomatic tricuspid regurgitation despite TTEER is not excluded. * Having transcatheter heart valve implants at risk of compression by TRAIPTA based on anatomic location on pre-procedure CT * Severe pulmonary artery hypertension, pulmonary artery systolic pressure \>=60 mm Hg * Severe baseline renal excretory dysfunction, eGFR\<30mL/min/1.73m\^2 unless on renal replacement therapy * Evidence of thrombus in left atrial appendage on baseline CTA * Known hypersensitivity to study device materials (for example, nickel) * Acute coronary syndrome, myocardial infarction, or percutaneous coronary intervention within 30 days * Requiring other structural heart intervention or coronary revascularization procedure in next 3 months * Pregnancy or intent to become pregnant prior to completion of all 12-month protocol follow-up procedures

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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.

  1. The places running it

    2 sites. 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.

    Open the record ↗

  3. 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

  • Emory University

    Atlanta, Georgia, 30308, United States

  • St. Francis Hospital and Heart Center

    Roslyn, New York, 11576, United States

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