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

Collect and evaluate the long term safety data.

Completed

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

l'Institut universitaire de cardiologie et de pneumologie de Québec, Québec, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

Subject currently participating in another investigational device or drug study.
Subject is unable or unwilling to return for the required follow-up visits.

Treatment and study plan

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

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

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Long Term Follow-up of the 23mm Portico™ Aortic Valve Implant and the SJM Transfemoral Delivery System

Important dates

Study start: 2011
Primary completion: 2012
Study completion: 2014
First posted: Dec 22, 2011
Registry last updated: Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed