Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT03016169
Eligibility Criteria:
Inclusion Criteria:
1. 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.
2. Subject is of legal age in the country where the subject is enrolled.
3. Subject must be willing and able to provide written informed consent to participate in this study.
4. Subject must be willing and able to comply with all follow-up requirements.
Exclusion Criteria:
1. Subject undergoes a concomitant procedure of mitral or tricuspid valve replacement at the time of the Trifecta GT valve implantation surgery.
2. Subject has contraindication for cardiac surgery.
3. Subject is pregnant. Pregnancy will be assessed by the subject informing the physicians.
4. 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).
5. Subject has had a stroke or transient ischemic attack within 6 months prior to the planned valve implantation surgery.
6. Subject is undergoing renal dialysis.
7. Subject has a history of active drug addiction, active alcohol abuse, or psychiatric hospital admission for psychosis within the prior 2 years.
8. Subject has a documented thrombus in the left atrium or left ventricle at the time of the valve implantation surgery.
9. Subject has a left ventricular ejection fraction \< 30%.
10. Subject previously enrolled in the Trifecta GT PMCF study and withdrawn (a subject cannot be enrolled twice in this study).
11. Preoperative evaluation indicates other significant cardiovascular abnormalities such as aortic dissection or ventricular aneurysm.
12. Subject has a life expectancy less than 2 years.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03016169
Study Brief:
Protocol Section:
NCT03016169