Brief Title
PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Official Title
Transfemoral Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (EUROPE)
Brief Summary
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
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
Study Type
Interventional
Primary Outcome
Number of Deaths
Secondary Outcome
Number of Participants With a Stroke
Condition
Aortic Valve Stenosis
Intervention
Sapien XT™ transcatheter heart valve and delivery system
Study Arms / Comparison Groups
TAVR
Description: Transaortic Valve Replacement
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
214
Start Date
December 2008
Completion Date
March 2016
Primary Completion Date
December 2010
Eligibility Criteria
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).
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Prof. Dr. Stefan Sack, ,
Location Countries
Belgium
Location Countries
Belgium
Administrative Informations
NCT ID
NCT00820599
Organization ID
2008-04
Responsible Party
Sponsor
Study Sponsor
Edwards Lifesciences
Study Sponsor
Prof. Dr. Stefan Sack, Study Director, Cardiology Clinic of Schwabing Clinic
Verification Date
October 2020