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

NCT01238835 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2020-11-02

Study results available
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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.

Conditions

  • Aortic Valve Stenosis

Interventions

DEVICE

SAPIEN XT™ Transapical aortic valve replacement

Transcatheter aortic valve implantation via the transapical approach

Sponsors & Collaborators

  • Edwards Lifesciences

    lead INDUSTRY

Principal Investigators

  • Prof. Dr. Thomas Walther · Kerckhoff Klinik

  • Dr. Olaf Wendler · King's College London

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-02-28
Completion
2016-03-31

Countries

  • Austria
  • France
  • Germany
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01238835 on ClinicalTrials.gov