N/A
N=358
Trifecta™ GT Post Market Clinical Follow-up
Aortic Valve Disease · Aortic Valve Disorder
Bottom Line
View on ClinicalTrials.gov: NCT03016169 ↗Enrolled (actual)
358
Serious AEs
57.5%
Results posted
May 2024
Primary outcome: Primary: Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation — 95.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Trifecta GT (Glide Technology) Valve (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abbott Medical Devices
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation |
95.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Subject is a candidate for surgical aortic valve replacement per current guidelines and is intended to be implanted with a St. Jude Medical Trifecta GT valve.
- Subject is of legal age in the country where the subject is enrolled.
- Subject must be willing and able to provide written informed consent to participate in this study.
- Subject must be willing and able to comply with all follow-up requirements.
Exclusion Criteria
- Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the Trifecta GT valve implantation surgery.
- Subject has contraindication for cardiac surgery.
- Subject is pregnant. Pregnancy will be assessed by the subject informing the physicians.
- Subject has active endocarditis (subjects who have previously experienced endocarditis must have two documented negative blood culture results while off antibiotic therapy prior to the valve implantation surgery).
- Subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery.
- Subject is undergoing renal dialysis.
- Subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
- Subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery.
- Subject has a left ventricular ejection fraction < 30%.
- Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study).
- Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
- Subject has a life expectancy less than 2 years.
Data sourced from ClinicalTrials.gov (NCT03016169). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.