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

NCT ID: NCT01497418

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2014-03-31

Brief Summary

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Collect and evaluate the long term safety data.

Detailed Description

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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.

Conditions

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Aortic Valve Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abbott Medical Devices

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Webb, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Health Care - St. Paul's Hospital

Locations

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l'Institut universitaire de cardiologie et de pneumologie de Québec

Québec, , Canada

Site Status

St. Paul's Hospital

Vancouver, , Canada

Site Status

Countries

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Canada

Other Identifiers

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1102

Identifier Type: -

Identifier Source: org_study_id

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