333
Participants
Start Date
September 17, 2019
Primary Completion Date
January 12, 2023
Study Completion Date
December 31, 2027
Portico™ NG (Navitor) Valve and FlexNav™ Delivery System
Subjects will undergo transcatheter aortic valve implantation (TAVI) with the new generation Portico NG (Navitor) valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
Subjects will undergo transcatheter aortic valve implantation (TAVI) with the Navitor Titan valve and large FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
Rigshospitalet, Copenhagen
The Alfred Hospital, Melbourne
St. Andrew's Hospital, Adelaide
Fiona Stanley Hospital, Murdoch
Columbia University Medical Center/NYPH, New York
Montefiore Medical Center - Moses Division, New York
Albany Medical Center, Albany
University of Pittsburgh Medical Center, Pittsburgh
Washington Hospital Center, Washington D.C.
Policlinico San Donato, San Donato Milanese
Sentara Norfolk General Hospital, Norfolk
Mission Health & Hospitals, Asheville
Baptist Memorial Hospital, Memphis
University Hospitals Cleveland Medical Center, Cleveland
St. Vincent Hospital, Indianapolis
Sparrow Clinical Research Institute, Lansing
Minneapolis Heart Institute, Minneapolis
Advocate Christ Medical Center, Oak Lawn
Via Christi Regional Medical Center, Wichita
The Heart Hospital Baylor Plano, Plano
The Methodist Hospital, Houston
Intermountain St. George Regional Hospital, St. George
Cedars-Sinai Medical Center, Los Angeles
Los Robles Regional Medical Center, Thousand Oaks
Providence St. Vincent Medical Center, Portland
Atlantic Health System - Morristown Memorial Hospital, Morristown
Royal Victoria Hospital, Belfast
Morriston Hospital - ABM University Health Board, Morriston
Lead Sponsor
Abbott Medical Devices
INDUSTRY