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

Edwards Lifesciences

Status: Completed

Conditions: Aortic Valve Stenosis

Treatments: Device: SAPIEN XT™ Transapical aortic valve replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT01238835

2009-06

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

TAVR-TA

Experimental group

Description:

Transcatheter valve replacement with transapical access

Treatment:

Device: SAPIEN XT™ Transapical aortic valve replacement