Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the St. Jude Medical Transfemoral Delivery System

Completed

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT01497418
• Lead Sponsor: Abbott Medical Devices

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-02
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-22
• Primary Completion: 2012-07
• Study Completion: 2014-03
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The objective of this study is to retrospectively and prospectively collect and evaluate the long term safety of the 23mm Portico Transcatheter Aortic Heart	1 year	Data will be collected at 3 months, 6 months, and 12 months post-implant.

Trial Locations

Locations (2)

l'Institut universitaire de cardiologie et de pneumologie de Québec; 🇨🇦 Quebec, Canada

St. Paul's Hospital; 🇨🇦 Vancouver, Canada