Trifecta™ GT Post Market Clinical Follow-up
Completed · Not applicable
Conditions studied: Aortic Valve Disease, Aortic Valve Disorder
In brief
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.
Key facts
- Study ID
- NCT03016169
- Run by
- Abbott Medical Devices
- People needed
- 358
- Starts
- 2017-03-09
- Expected to finish
- 2023-08-31
- Last updated by the study team
- 2025-02-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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- Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study).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.
Where it is running
- Mayo Clinic — Rochester, Minnesota, United States
- Mission Health & Hospitals — Asheville, North Carolina, United States
- Main Line Health Center/Lankenau Hospital — Wynnewood, Pennsylvania, United States
- Centennial Medical Center — Nashville, Tennessee, United States
- CHI St. Luke's Health Baylor College of Medicine — Houston, Texas, United States
- Cliniques Universitaires Saint Luc — Brussels, Brussels Capital, Belgium
- Saint John Regional Hospital - New Brunswick Heart Centre — Saint John, New Brunswick, Canada
- Toronto General Hospital — Toronto, Ontario, Canada
- Institut de Cardiologie de Montreal — Montreal, Quebec, Canada
- Tartu University Hospital — Tartu, Estonia
- CHRU Hopital de Pontchaillou — Rennes, Brittany Region, France
- Kerckhoff-Klinik gGmbH — Bad Nauheim, Hesse, Germany
- Krankenhaus der Barmherzigen Brüder — Trier, Rhineland-Palatinate, Germany
- Herzzentrum Leipzig GmbH — Leipzig, Saxony, Germany
- Universitätsklinikum Jena — Jena, Thuringia, Germany
- Deutsches Herzzentrum Berlin — Berlin, Germany
- Asklepios Klinik Harburg — Hamburg, Germany
- Ospedale Niguarda Ca'Granda — Milan, Lombardy, Italy
- Az. Osp Universitaria Careggi — Florence, Tuscany, Italy
- Ospedale dell'Angelo — Mestre, Veneto, Italy
- Catharina Ziekenhuis — Eindhoven, North Brabant, Netherlands
- Centralny Szpital Kliniczny MSW w Warszawie — Warsaw, Masovian Voivodeship, Poland
- Hospital de São João — Porto, Portugal
- Hospital Universitario del Vinalopó — Elche, Alicante, Spain
- Hospital Universitario Son Espases — Palma de Mallorca, Balearic Island, Spain
Full record on ClinicalTrials.gov
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