Brief Title
Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System
Official Title
Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the SJM Transfemoral Delivery System
Brief Summary
Collect and evaluate the long term safety data.
Detailed 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.
Study Type
Observational
Primary Outcome
The objective of this study is to retrospectively and prospectively collect and evaluate the long term safety of the 23mm Portico Transcatheter Aortic Heart
Condition
Aortic Valve Stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
2
Start Date
December 2011
Completion Date
March 2014
Primary Completion Date
July 2012
Eligibility Criteria
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.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
John Webb, MD, ,
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT01497418
Organization ID
1102
Responsible Party
Sponsor
Study Sponsor
Abbott Medical Devices
Study Sponsor
John Webb, MD, Principal Investigator, Providence Health Care - St. Paul's Hospital
Verification Date
February 2019