Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System
This trial is active, not recruiting.
|Condition||aortic valve stenosis|
|Sponsor||St. Jude Medical|
|Start date||December 2011|
|End date||June 2014|
|Trial size||2 participants|
|Trial identifier||NCT01497418, 1102|
Collect and evaluate the long term safety data.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
The objective of this study is to retrospectively and prospectively collect and evaluate the long term safety of the 23mm Portico Transcatheter Aortic Heart
time frame: 1 year
Male or female participants at least 18 years old.
Inclusion Criteria: 1. Subject has given written study Informed Consent for participation prior to any study procedures. 2. Subject is ≥ 18 years of age or legal age in host country at time of consent. 3. Subject currently has a 23mm SJM Portico Transfemoral Transcatheter Heart Valve Exclusion Criteria: 1. Subject currently participating in another investigational device or drug study. 2. Subject is unable or unwilling to return for the required follow-up visits.
|Official title||Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the SJM Transfemoral Delivery System|
|Principal investigator||John Webb, MD|
|Description||The purpose of this study is to collect and evaluate the long term safety data of the 23mm Portico™ Transcatheter Heart Valve and the transfemoral Delivery System previously implanted in subjects with aortic valve disease.|
Call for more information