Overview

This trial is active, not recruiting.

Condition aortic valve stenosis
Treatment sapien xt™ transapical aortic valve replacement
Sponsor Edwards Lifesciences
Start date September 2009
End date February 2011
Trial size 218 participants
Trial identifier NCT01238835, 2009-06

Summary

A single arm, prospective multicenter non-randomized confirmatory clinical trial evaluating the Edwards SAPIEN XT™ transcatheter heart valve (model 9300TFX; "study valve"), the next generation Ascendra™ transapical 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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
sapien xt™ transapical aortic valve replacement Sapien XT
Transcatheter aortic valve implantation via the transapical approach

Primary Outcomes

Measure
Freedom from death
time frame: 30 days

Secondary Outcomes

Measure
Safety
time frame: 5 years
Efficacy parameters
time frame: 5 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion: 1. EuroSCORE of ≥ 15 % 2. severe senile degenerative aortic valve stenosis … 3. symptomatic aortic valve stenosis… 4. Informed consent 5. Compliance Exclusion: 1. Logistic Euroscore > 40 % 2. Evidence of an acute myocardial infarction .. 3. congenital unicuspid or congenital bicuspid valve/ non-calcified. 4. Mixed aortic valve disease .. 5. annulus size < 18 mm or > 27mm 6. Pre-existing prosthetic heart valve in any position 7. Any therapeutic invasive cardiac procedure.. 8. Severe ventricular dysfunction 9. Gorlin Conundrum (AV low flow, low gradient) 10. Untreated clinically significant coronary artery disease requiring revascularization. 11. Echocardiographic evidence of intracardiac mass, thrombus/ vegetation /presence /left ventricular aneurysm 12. Blood dyscrasias.. 13. Hemodynamic instability .. 14. Emergency intervention 15. Hypertrophic obstructive cardiomyopathy 16. Active infection / endocarditis. 17. Active peptic ulcer or upper GI bleeding… 18. A known hypersensitivity or contraindication to aspirin, heparin, ticlopidine (Ticlid), or clopidogrel (Plavix/Iscover), or sensitivity to contrast media, which cannot be adequately premedicated. 19. Recent CVA or TIA .. 20. Severe renal insufficiency 21. Life expectancy < 12 months due to non-cardiac comorbid conditions. 22. Pregnant or lactating woman 23. Currently participating in an investigational drug or another device study

Additional Information

Official title Prevail TA Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)
Principal investigator Prof. Dr. Thomas Walther
Description Edwards Lifesciences obtained CE marking authorization for transapical delivery / implantation of the Edwards SAPIEN™ transcatheter heart valve (model 9000TFX) using the first generation Ascendra™ delivery system in 2007 and introduced these devices for commercial distribution in the European Economic Area (EEA) the same year. This trial incorporates iterated products for this procedure. Purpose: The purpose of this trial is to evaluate the acute safety and effectiveness of the SAPIEN XT™ study valve and next generation Ascendra™ delivery components. Enrollment: In total, a minimum of 150 patients will be enrolled to receive the study valve under this protocol. An application for CE marking authorization will be submitted to the EC Notified Body during the course of the trial. Enrollment of the remaining patients will continue after the receipt of CE mark certification as part of a post market surveillance plan. Follow-up Intervals: Subject data collection will include clinical information at baseline and during the index procedure. Subjects will undergo clinical follow-up at discharge, 30 days, 6 month annually for 5 years. Clinical Sites: Approximately 10 sites in Europe PREVAIL TA Continued Access: After inclusion of 150 patients, continued access will be provided to patients requiring a 29 mm valve until receipt of CE-mark. Approximately 50 patients are expected to be enrolled in the continued access and it will be conducted under the same protocol with the same inclusion/exclusion criteria and primary and secondary endpoints. Up to 10 additional sites will be added.
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.