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

Study Design

Observational model cohort

Primary Outcomes

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

Eligibility Criteria

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.

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by St. Jude Medical.