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

Abbott Medical Devices6 sites in 1 country245 target enrollmentFebruary 2012

ConditionsHeart Valve Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Heart Valve Diseases
Sponsor: Abbott Medical Devices
Enrollment: 245
Locations: 6
Primary Endpoint: Late Adverse Event Incidence
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

October 2014

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Abbott Medical Devices

Responsible Party

Sponsor

Eligibility Criteria

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

Exclusion Criteria

•Subject currently participating in another device or drug study
•Subject unable or unwilling to return for study follow-up visits

Outcomes

Primary Outcomes

Late Adverse Event Incidence

Time Frame: 5 years

Late patient years are calculated from 31 days post-implant to the date of the last follow-up visits (or contact) or adverse events. Late Patient year calculation:\[(Number of late adverse events/sum of late patient years) x 100\]