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

Study Overview
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Brief Summary
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A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; study valve), its transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.

Detailed Description
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Edwards Lifesciences obtained CE marking authorization for transfemoral delivery / implantation of the Edwards SAPIEN™ transcatheter heart valve (model 9000TFX) using the RetroFlex™ delivery system in August 2007 and introduced these devices for commercial distribution in the European Economic Area (EEA) in October 2007. Clinical Sites: Up to 11 sites in Europe

Official Title
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Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)

Conditions
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Aortic Valve Stenosis

Intervention / Treatment
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* Device: Sapien XT™ transcatheter heart valve and delivery system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All candidates for this study must meet all of the following inclusion criteria: 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%. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater. 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. Subject is willing to comply with specified follow up evaluations, including possible coronary angiography and transesophageal echocardiography. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits. Exclusion Criteria: Aortic valve is a congenital unicuspid or bicuspid valve, or is non-calcified. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation >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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAVR<br>Transaortic Valve Replacement | Device: Sapien XT™ transcatheter heart valve and delivery system<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Deaths | Number of death at 30-days from the index procedure. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With a Stroke | Total number of participates with a stroke. | 30 days from the index procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sapien Valve, Cardiovascular Diseases, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transfemoral, Transcatheter