Trifecta™ GT Post Market Clinical Follow-up

Status Completed

Clinical Trial Summary

The objective of this study is to evaluate the safety and performance of the Trifecta™ GT (Glide Technology) valve through 5 year follow-up in a prospective, multi-center, real-world setting. This study is intended to satisfy post-market clinical follow-up requirements of CE Mark in Europe.

Clinical Trial Description

The study is a prospective multi-center evaluation of approximately 350 subjects implanted with a St. Jude Medical (SJM) Trifecta™ GT valve. It will be conducted in approximately 35 sites worldwide. Subjects will be followed for 5 years. The total duration of the study is expected to be 6 years, assuming all subjects are enrolled within 1 year of study initiation. To ensure enrollment balance across sites, no individual site can enroll more than 10% of the sample size (n=35 subjects) without prior approval from the sponsor. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03016169
Study type	Interventional
Source	Abbott Medical Devices
Contact
Status	Completed
Phase	N/A
Start date	March 9, 2017
Completion date	August 31, 2023

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