Trifecta™ GT Post Market Clinical Follow-up
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03016169|
Recruitment Status : Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : February 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Aortic Valve Disease Aortic Valve Disorder||Device: Trifecta GT (Glide Technology) Valve||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||363 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Trifecta™ GT (Glide Technology) Post Market Clinical Follow-up (PMCF)|
|Actual Study Start Date :||March 9, 2017|
|Estimated Primary Completion Date :||February 2023|
|Estimated Study Completion Date :||February 2023|
All subjects will receive the Trifecta GT valve
Device: Trifecta GT (Glide Technology) Valve
Surgical aortic valve replacement with Trifecta GT Valve.
- Freedom from surgical valve replacement or transcatheter valve-in-valve implantation [ Time Frame: 5 years post implant ]Determined by adverse event reporting
- Freedom from all-cause mortality [ Time Frame: 5 years post implant ]Determined by adverse event reporting
- Freedom from valve related mortality [ Time Frame: 5 years post implant ]Determined by adverse event reporting
- Freedom from structural valve deterioration [ Time Frame: 5 years post implant ]Determined by adverse event reporting
- Freedom from surgical valve replacement or transcatheter valve implantation due to structural valve deterioration [ Time Frame: 5 years post implant ]Determined by adverse event reporting
- Valve hemodynamic performance [ Time Frame: Up to 7 days, 6 months, 3 years and 5 years post implant ]Measured by echocardiogram
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03016169