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NCT06479824 · ClinicalTrials.gov registry record · NA
NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty (TRAIPTA) Early Feasibility Study
A NA study of Tricuspid Valve Insufficiency, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT06479824: Recruiting NA study of Tricuspid Valve Insufficiency, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT06479824 is a NA study of Tricuspid Valve Insufficiency that is actively recruiting participants, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 60 participants, below the 335-participant average among 6 other Tricuspid Valve Insufficiency trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06479824, a NA study of Tricuspid Valve Insufficiency, is actively recruiting participants, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study 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....
Conditions Studied
Interventions
- DEVICE TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty)
Study Locations (2)
Georgia
- Emory University - Atlanta
New York
- St. Francis Hospital and Heart Center - Roslyn
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-08-19 |
| Est. Completion | 2030-09-01 |
| Phase | NA |
What NCT06479824 shows while recruiting
NCT06479824 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 335-participant average among 6 other Tricuspid Valve Insufficiency trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Tricuspid Valve Insufficiency appearing as the primary indexed condition, and to 1 intervention - of which TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty) is the first listed.
NCT06479824 reports a single indexed study location in Georgia, New York.
Frequently Asked Questions
What is clinical trial NCT06479824 about?
NCT06479824 is a clinical study titled "NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty (TRAIPTA) Early Feasibility Study". 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...
What is the current status of trial NCT06479824?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2025-08-19. Estimated completion is 2030-09-01.
What conditions does trial NCT06479824 study?
This clinical trial studies the following conditions: Tricuspid Valve Insufficiency.
What interventions are being tested in trial NCT06479824?
The interventions under investigation include: TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty) (DEVICE).
Who is sponsoring clinical trial NCT06479824?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06479824 being conducted?
This trial has 2 study locations across Georgia, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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