PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Sapien Valve, Cardiovascular Diseases, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transfemoral, Transcatheter Read More

Inclusion Criteria:

All candidates for this study must meet all of the following inclusion criteria:

1. Patients must have co-morbidities such that the surgeon (Co Investigator) and interventional cardiologist (Principal Investigator) concur that the predicted risk of operative mortality is > 15% with a minimum STS Risk Calculator score of ≥ 10 and/or Logistic EuroSCORE of > 20%.
2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
3. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided a written informed consent that has been approved by the reviewing Ethics Committee (EC) of the respective clinical site.
4. Subject is willing to comply with specified follow up evaluations, including possible coronary angiography and transesophageal echocardiography.
5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria:

1. Aortic valve is a congenital unicuspid or bicuspid valve, or is non-calcified.
2. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >3+).
3. Any therapeutic invasive cardiac procedure, other than BAV, performed within 30 days of the index procedure (or 6 months if the procedure was a drug eluting coronary stent implantation).