NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty (TRAIPTA) Early Feasibility … (NCT06479824) | Clinical Trial Compass
SuspendedNot Applicable
NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty (TRAIPTA) Early Feasibility Study
Stopped: Enrollment has been put on hold by the sponsor to allow for further engineering evaluation and performance review of the investigational device, as well as reassessment of the underlying device reliability assumptions.
United States60 participantsStarted 2025-08-19
Plain-language summary
Background:
Tricuspid valve regurgitation is a disease where one of the heart valves leaks. The leak affects blood flow. People with this disease may feel breathless and lack energy; they may need to stay in the hospital when fluid builds up in the body. The tricuspid is the most difficult valve to repair with surgery. Researchers want to try a new procedure called trans-atrial intra-pericardial tricuspid annuloplasty (TRAIPTA).
Objective:
To test TRAIPTA in people with tricuspid valve regurgitation.
Eligibility:
Adults aged 21 years and over with tricuspid valve regurgitation. They must not be eligible for standard surgical repair.
Design:
Participants will be screened. They will have tests of their heart function; these will include blood tests, imaging scans, and a 6-minute walking test.
Participants will enter the hospital for at least 1 day. The TRAIPTA procedure will be done under sedation or general anesthesia. The TRAIPTA study device is a loop that will be placed around the heart like a belt. It acts like a lasso to reduce leakage of the heart valve. Doctors will put the device in place by inserting a wire through a vein in the leg; they will thread the device up to the heart through the vein. The wire will be removed, but the TRAIPTA device will remain in place.
Participants will have follow-up visits 4 times in 1 year after the procedure. These visits will include physical exams, blood tests, imaging scans, and other tests of heart function.
Researchers will contact participants or their doctors for heart test results for another 4 years....
Who can participate
Age range
21 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial's recruitment is currently suspended, can you find out why it was paused and whether it's expected to resume — and how that affects my options right now?
2This is an early feasibility study focused on safety rather than proven effectiveness, so what does that mean for the level of uncertainty I'd be taking on compared to standard treatments for tricuspid valve insufficiency?
3The TRAIPTA procedure is described as trans-atrial and intra-pericardial, which sounds like a less invasive approach — can you explain how this compares in risk and recovery to the surgical or catheter-based options already available to me?
4Because this is a feasibility study, the number of patients enrolled is likely very small — does that mean there's limited safety data so far, and how would you weigh that uncertainty against my current condition?
5If this trial remains suspended or I don't end up being a candidate, what are the standard-of-care alternatives you'd recommend for my degree of tricuspid valve insufficiency?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety of TRAIPTA procedure
Timeframe: 30 days
Trial details
NCT IDNCT06479824
SponsorNational Heart, Lung, and Blood Institute (NHLBI)