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

Edwards Lifesciences220 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

220

Conditions

Aortic Valve Stenosis

Interventions

SAPIEN XT™ Transapical aortic valve replacementDEVICE

Transcatheter aortic valve implantation via the transapical approach

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (20)

Medizinische Universitat Wien Univ.Klinik f.Chirurgie

Vienna, Austria

Hôspital Bichat

Paris, France

Outcomes

Primary Outcomes

Number of Deaths

Number of death at 30-days from the index procedure.

Time frame: 30 days

Secondary Outcomes

Number of Participants With a Stroke

Total Number of Participants with a Stroke.

Time frame: 30-days

Data from ClinicalTrials.gov

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