Overview

This trial has been completed.

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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Intervention model single group assignment
Primary purpose treatment
Masking no masking
Arm
(Experimental)
Transcatheter valve replacement with transapical access
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

All 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

Additional Information

Official title Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)
Principal investigator Prof. Dr. Thomas Walther
Description 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. 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2017.
Information provided to ClinicalTrials.gov by Edwards Lifesciences.