Trifecta™ GT Post Market Clinical Follow-up

Not Applicable

Completed

Conditions: Aortic Valve Disease
Aortic Valve Disorder

Interventions: Device: Trifecta GT (Glide Technology) Valve

Registration Number: NCT03016169

Lead Sponsor: Abbott Medical Devices

Brief 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 358

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Trifecta GT (Glide Technology) Valve	All subjects will receive the Trifecta GT valve

Primary Outcome Measures

Name	Time	Method
Freedom From Surgical Valve Replacement or Transcatheter Valve-in-Valve Implantation	5 years post implant	Estimated percentage of participants free from undergoing an additional aortic valve replacement within 5 years, using a Kaplan-Meier estimate.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (27): Main Line Health Center/Lankenau Hospital
🇺🇸
Wynnewood, Pennsylvania, United States
Tartu University Hospital
🇪🇪
Tartu, Estonia
Centralny Szpital Kliniczny MSW w Warszawie
🇵🇱
Warsaw, Mazovia, Poland
Institut de Cardiologie de Montreal
🇨🇦
Montréal, Quebec, Canada
Ospedale Niguarda Ca'Granda
🇮🇹
Milano, Lombardy, Italy
Hospital Universitario del Vinalopó
🇪🇸
Elche, Alicante, Spain
Krankenhaus der Barmherzigen Brüder
🇩🇪
Trier, Rhineland-Palatinate, Germany
Cliniques Universitaires Saint Luc
🇧🇪
Brussels, Brussels - Capital Region, Belgium
Universitätsklinikum Jena
🇩🇪
Jena, Thuringia, Germany
Catharina Ziekenhuis
🇳🇱
Eindhoven, Noord-Brabant, Netherlands
Kerckhoff-Klinik gGmbH
🇩🇪
Bad Nauheim, Hesse, Germany
Hospital de São João
🇵🇹
Porto, Portugal
Az. Osp Universitaria Careggi
🇮🇹
Firenze, Tuscany, Italy
CHRU Hopital de Pontchaillou
🇫🇷
Rennes, Brittany, France
Deutsches Herzzentrum Berlin
🇩🇪
Berlin, Germany
Herzzentrum Leipzig GmbH
🇩🇪
Leipzig, Saxony, Germany
Asklepios Klinik Harburg
🇩🇪
Hamburg, Germany
Ospedale dell'Angelo
🇮🇹
Mestre, Veneto, Italy
St. Bartholomew's Hospital
🇬🇧
London, United Kingdom
Plymouth Hospitals NHS Trust - Derriford Hospital
🇬🇧
Plymouth, South West England, United Kingdom
Hospital Universitario Son Espases
🇪🇸
Palma de Mallorca, Balearic Island, Spain
Mayo Clinic
🇺🇸
Rochester, Minnesota, United States
Mission Health & Hospitals
🇺🇸
Asheville, North Carolina, United States
Centennial Medical Center
🇺🇸
Nashville, Tennessee, United States
CHI St. Luke's Health Baylor College of Medicine
🇺🇸
Houston, Texas, United States
Saint John Regional Hospital - New Brunswick Heart Centre
🇨🇦
Saint John, New Brunswick, Canada
Toronto General Hospital
🇨🇦
Toronto, Ontario, Canada