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Trifecta™ GT Post Market Clinical Follow-up

NCT03016169 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2025-02-11

Study results available
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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.

Conditions

  • Aortic Valve Disease
  • Aortic Valve Disorder

Interventions

DEVICE

Trifecta GT (Glide Technology) Valve

Surgical aortic valve replacement with Trifecta GT Valve.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Barathi Sethuraman · Abbott Structural Heart

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-09
Primary Completion
2023-04-25
Completion
2023-08-31
FDA Device
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Estonia
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03016169 on ClinicalTrials.gov