Heart lasso: new catheter belt tightens leaky valve without surgery
NCT ID NCT06479824
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
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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 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2025
- Expected to finish
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Sep 2030
An estimate. End dates often move.
- Lead sponsor
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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
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21 to 100 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: * 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.
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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
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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Emory University
Atlanta, Georgia, 30308, United States
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St. Francis Hospital and Heart Center
Roslyn, New York, 11576, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New device could fix leaky heart valves without Open-Heart surgery
- New heart valve device aims to fix tricuspid leak without open surgery
- New heart valve device aims to fix tricuspid leak without open surgery
- New heart valve device aims to ease severe leak
- New heart valve replacement could help thousands avoid Open-Heart surgery
- Heart valve fix may also shield kidneys in seniors