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

Abbott Medical Devices2 enrolled

Overview

Collect and evaluate the long term safety data.

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

Enrollment

Conditions

Aortic Valve Stenosis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

l'Institut universitaire de cardiologie et de pneumologie de Québec

Québec, Canada

St. Paul's Hospital

Vancouver, Canada

Outcomes

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

Data will be collected at 3 months, 6 months, and 12 months post-implant.

Time frame: 1 year

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.