Trifecta™ GT Post Market Clinical Follow-up
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-003742
NCT ID: NCT03016169
Sponsor Protocol Number: SJM-CIP-10120
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Hartzell Schaff, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available