At a glance
ClinicalIndex Comparison RecordN/ACompleted· 358 enrolled
Drug / intervention
Trifecta GT (Glide Technology) Valvedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)
In Brief
A clinical study evaluating Trifecta GT (Glide Technology) Valve for Aortic Valve Disease and Aortic Valve Disorder. Completed, enrolled 358 participants across 27 sites in 12 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Valve Disease, Aortic Valve Disorder
CountriesBelgium, Canada, Estonia, France, Germany, Italy, Netherlands, Poland, Portugal, Spain, United Kingdom, United States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2017
Enrollment StartMar 2017
Primary CompletionApr 2023
Study CompletionAug 2023
TodayJul 2026
First PostedJan 10, 2017
Enrollment StartMar 9, 2017
Primary CompletionApr 25, 2023
Study CompletionAug 31, 2023
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 9.5 years ago
Interventions
Trifecta GT (Glide Technology) Valvedevice
Surgical aortic valve replacement with Trifecta GT Valve.