Status:
COMPLETED
PREVAIL-TF: Transfemoral Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Lead Sponsor:
Edwards Lifesciences
Conditions:
Aortic Valve Stenosis
Eligibility:
All Genders
18+ years
Phase:
NA
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 s...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT00820599
Start Date
December 1 2008
End Date
March 1 2016
Last Update
November 2 2020
Active Locations (11)
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1
Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst
Aalst, Belgium, 9300
2
Institut Hospitalier Jacques Cartier
Massy, France, 91300
3
Hospital Bichat Claude Bernard
Paris, France, 75018
4
CHU Hospital Charles Nicolle
Rouen, France, 76000