Post-Approval Study Protocol of the St. Jude Medical Trifecta Valve

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

245 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2014-10-31

Brief Summary

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To further evaluate the long term clinical safety and effectiveness of the Trifecta valve

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Detailed Description

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To further evaluate the long term clinical safety and effectiveness of the Trifecta valve in subjects who had a Trifecta valve implanted during the IDE study.

Conditions

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Heart Valve Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trifecta Valve Group

Subjects implanted with a Trifecta valve.

Group Type EXPERIMENTAL

Trifecta valve

Intervention Type DEVICE

surgical replacement of aortic valve

Interventions

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Trifecta valve

surgical replacement of aortic valve

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subjects implanted with a Trifecta valve at one of the US sites of the IDE study.
* Subject met eligibility criteria of IDE study
* Subject agrees to complete study follow-up visits
* Subject provides written informed consent