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NCT01497418 Clinical Trial

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

Aortic Valve Stenosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01497418
Other study ID # 1102
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 2011
Est. completion date March 2014

Study information
Verified date February 2019
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Collect and evaluate the long term safety data.

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.

Recruitment information / eligibility
Status Completed
Enrollment 2
Est. completion date March 2014
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Canada l'Institut universitaire de cardiologie et de pneumologie de Québec Quebec
Canada St. Paul's Hospital Vancouver

Sponsors (1)
Lead Sponsor Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 1 year
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