NCT06458907 - TRICAV-II Pivotal: TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation. | Biotech Hunter

Enrollment

600

Participants

Timeline

Start Date

December 31, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

January 31, 2030

Conditions

Tricuspid RegurgitationTricuspid Valve Disease

Interventions

DEVICE

TricValve® Transcatheter Bicaval Valve System

TricValve® Device (Device) Group subjects will undergo TricValve® implantation and will continue to be managed with optimal medical therapies.

DRUG

Optimal medical therapy

Trial Locations (15)

10032

Columbia University Medical Center/ NewYork Presbyterian Hospital, Irving

10467

Montefiore Medical Center, The Bronx

17107

UPMC Pinnacle, Harrisburg

20010

MedStar Washington Hospital Center, Multiple Locations

33606

Tampa General Hospital, Tampa

44106

Cleveland Clinic, Cleveland

46260

Ascension Medical Group St. Vincent The Heart Center of Indiana, Indianapolis

55407

Minneapolis Heart Institute Foundation, Minneapolis

60201

Northshore Evanston Hospital, Evanston

70360

Cardiovascular Institute of the South, Houma

77030

Houston Methodist, Houston

University of Texas (Memorial Hermann), Houston

84107

Intermountain Heart Institute - Intermountain Medical Center, Murray

85013

St. Joseph's Hospital and Medical Center, Phoenix

92037

Scripps Memorial Hospital La Jolla, San Diego

All Listed Sponsors

collaborator

Meditrial USA Inc.

INDUSTRY

lead

P+F Products + Features USA Inc.

INDUSTRY