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NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty (TRAIPTA) Early Feasibility Study

NCT06479824 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-17

No results posted yet for this 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

  • Tricuspid Valve Insufficiency

Interventions

DEVICE

TRAIPTA (Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty)

In TRAIPTA, catheter tools cross the wall of the heart to enter the pericardial space surrounding the heart, encircle the heart around the atrioventricular groove, and apply tension to reshape and narrow the heart to help the leaky tricuspid valve to function better. After placing the belt, a closure device is deployed to close the puncture in the right atrial appendage.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Robert J Lederman, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-19
Primary Completion
2026-10-01
Completion
2030-09-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06479824 on ClinicalTrials.gov