NCT03016169

Trifecta™ GT Post Market Clinical Follow-up

Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 358 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Aortic Valve Disease
• Aortic Valve Disorder

Interventions

Type	Name	Description
DEVICE	Trifecta GT (Glide Technology) Valve	Surgical aortic valve replacement with Trifecta GT Valve.

Timeline

• Start date: 2017-03-09
• Primary completion: 2023-04-25
• Completion: 2023-08-31
• First posted: 2017-01-10
• Last updated: 2025-02-11
• Results posted: 2024-05-29

Locations

27 sites across 12 countries: United States, Belgium, Canada, Estonia, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated device study