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

Abbott

Status: Completed

Conditions: Aortic Valve Stenosis

Study type: Observational

Funder types: Industry

Identifiers

NCT01497418

1102

Details and patient eligibility

About

Collect and evaluate the long term safety data.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.