194
Participants
Start Date
October 17, 2024
Primary Completion Date
December 31, 2027
Study Completion Date
December 31, 2031
J-Valve Transfemoral (TF) System
Treatment includes using the J-Valve Transfemoral (TF) System, a transcatheter aortic valve replacement system that consists of the J-Valve TF Bioprosthesis and the J-Valve TF Delivery Device and Loading Accessories, during transcatheter aortic valve replacement (TAVR). The Edwards 16Fr eSheath+ Introducer Set may be used for the introduction and removal of the J-Valve TF System.
Montefiore Medical Center, The Bronx
Emory University Atlanta, Atlanta
NCH Rooney Heart Institute, Naples
Ascension St. Thomas West Hospital, Nashville
Vanderbilt University Medical Center, Nashville
The Lindner Research Center at The Christ Hospital, Cincinnati
Henry Ford Hospital Detroit, Detroit
Northwestern University Chicago, Chicago
Washington University - Barnes-Jewish Hospital St. Louis, St Louis
Ascension Via Christi, Wichita
Cardiovascular Institute of the South, Houma
HCA Houston Healthcare Medical Center, Houston
Houston Methodist Hospital, Houston
HonorHealth Research & Innovation Institute, Scottsdale
Cedars Sinai, Los Angeles
Swedish Heart & Vascular Research, Seattle
Massachusetts General Hospital Boston, Boston
Brigham and Women's Hospital, Boston
Minneapolis Heart Institute Foundation
OTHER
Cardiovascular Research Foundation, New York
OTHER
JC Medical, Inc., an affiliate of Edwards Lifesciences LLC
INDUSTRY