Portico Re-sheathable Transcatheter Aortic Valve System US IDE Trial (PORTICO)
The purpose of this study is to evaluate the safety and effectiveness of the new SJM Portico Transcatheter Heart Valve (the study device) and its delivery systems. This study will enroll subjects who are at high or extreme risk for aortic heart valve replacement with open heart surgery.
Transcatheter Aortic Valve Replacement (TAVR)
Includes but not limited to:
-At high or extreme risk for open heart valve replacement (as determined by the study doctor)
-Has not had any percutaneous coronary or peripheral interventional procedure (to improve blood flow) performed within 30 days before consent into this study
-Has not had an active peptic ulcer or upper GI bleed in the past 3 months
21 - 99
Healthy Volunteers Needed
Duration of Participation
About 5 years
Rebecca Boucher, RN
St. Jude Medical, Cardiology Division Inc.
Subjects will receive $25.00 to cover the cost of travel for attending required study visits.