Trifecta™ GT Post Market Clinical Follow-up

Abbott

Status

Completed

Conditions

Aortic Valve Disease

Aortic Valve Disorder

Treatments

Device: Trifecta GT (Glide Technology) Valve

Study type

Interventional

Funder types

Industry

Identifiers

NCT03016169

SJM-CIP-10120

Details and patient eligibility

About

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.

Full 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.

Enrollment

358 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.