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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01497418

Enrollment

Registered

2011-12-22

Start date

2011-12-31

Completion date

2014-03-31

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Canada

Outcome results