Status:
COMPLETED
Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System
Lead Sponsor:
Abbott Medical Devices
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- Subject has given written study Informed Consent for participation prior to any study procedures.
- Subject is ≥ 18 years of age or legal age in host country at time of consent.
- Subject currently has a 23mm SJM Portico Transfemoral Transcatheter Heart Valve
Exclusion
- Subject currently participating in another investigational device or drug study.
- Subject is unable or unwilling to return for the required follow-up visits.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01497418
Start Date
December 1 2011
End Date
March 1 2014
Last Update
February 4 2019
Active Locations (2)
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1
l'Institut universitaire de cardiologie et de pneumologie de Québec
Québec, Canada
2
St. Paul's Hospital
Vancouver, Canada