50
Participants
Start Date
July 23, 2024
Primary Completion Date
November 30, 2025
Study Completion Date
September 30, 2029
TricValve® Transcatheter Bicaval Valve System
The TricValve® Transcatheter Bicaval Valve System is a bicaval transcatheter tricuspid valve replacement system, which includes the TricValve® Transcatheter Bicaval Valve for superior vena cava (SVC) and the TricValve® Transcatheter Bicaval Valve for inferior vena cava (IVC). The system is a single use, sterile device compatible with all the valve sizes. The valves are premounted in the TricValve® Delivery System. The prostheses are implanted percutaneously into the inferior and superior vena cava without disturbing the native tricuspid valve. The device is made of bovine pericardium leaflets sutured on a nitinol self-expanding stent system available in sizes 25 and 29 for superior vena cava and 31 and 35 for inferior vena cava. The valve is implanted percutaneously by the transfemoral approach. The valves are supplied already premounted into the TricValve® Delivery System.
RECRUITING
Montefiore Medical Center, The Bronx
NOT_YET_RECRUITING
North Shore University Hospital, Manhasset
NOT_YET_RECRUITING
UPMC Presbyterian Shadyside, Pittsburgh
RECRUITING
UPMC Pinnacle, Harrisburg
NOT_YET_RECRUITING
WellSpan York Hospital, York
RECRUITING
MedStar Washington Hospital Center, Multiple Locations
RECRUITING
UVA School of Medicine, Charlottesville
NOT_YET_RECRUITING
Sentara Healthcare, Norfolk
NOT_YET_RECRUITING
Carilion Clinic, Roanoke
NOT_YET_RECRUITING
Duke Cardiology Clinic, Durham
NOT_YET_RECRUITING
MUSC, Charleston
NOT_YET_RECRUITING
Delray Medical Center, Delray Beach
RECRUITING
Tampa General Hospital, Tampa
RECRUITING
Largo Medical Center, Largo
NOT_YET_RECRUITING
Riverside Methodist Hospital, Columbus
RECRUITING
Cleveland Clinic, Cleveland
RECRUITING
Ascension Medical Group St. Vincent The Heart Center of Indiana, Indianapolis
RECRUITING
Minneapolis Heart Institute Foundation, Minneapolis
RECRUITING
Endeavor Health, Glenbrook Hospital, Glenview
NOT_YET_RECRUITING
Chicago Advocate Christ, Palos Park
NOT_YET_RECRUITING
Washington University St Louis, St Louis
NOT_YET_RECRUITING
Saint Luke's Mid America Heart Institute, Kansas City
RECRUITING
Cardiovascular Institute of the South, Houma
RECRUITING
Houston Methodist, Houston
RECRUITING
University of Texas (Memorial Hermann), Houston
RECRUITING
Intermountain Heart Institute - Intermountain Medical Center, Murray
RECRUITING
St. Joseph's Hospital and Medical Center, Phoenix
NOT_YET_RECRUITING
Tucson Medical Center, Tucson
RECRUITING
Scripps Memorial Hospital La Jolla, San Diego
NOT_YET_RECRUITING
UCSF, San Francisco
NOT_YET_RECRUITING
Oregon Health Services, Portland
NOT_YET_RECRUITING
Swedish Medical Center, Seattle
RECRUITING
Massachusetts General Hospital, Boston
NOT_YET_RECRUITING
Beth Israel Deaconess Medical Center, Boston
RECRUITING
Lahey Hospital & Medical Center, Burlington
NOT_YET_RECRUITING
Hackensack University Medical Center, Hackensack
P+F Products + Features GmbH
INDUSTRY
Meditrial USA Inc.
INDUSTRY
P+F Products + Features USA Inc.
INDUSTRY