NCT06479824View on ClinicalTrials.gov

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

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 28, 2025

Primary Completion Date

October 1, 2026

Study Completion Date

September 1, 2030

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.

Trial Locations (4)

11576

St. Francis Hospital and Heart Center, Roslyn

20010

Medstar WHC, Washington D.C.

24014

Carilion Medical Center, Roanoke

30308

Emory University, Atlanta

All Listed Sponsors
lead

National Heart, Lung, and Blood Institute (NHLBI)

NIH

NCT06479824 - NHLBI and Cook Trans-Atrial Intra-Pericardial Tricuspid Annuloplasty (TRAIPTA) Early Feasibility Study | Biotech Hunter | Biotech Hunter