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Completed

NCT Number: NCT01238835

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

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.

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Key information

Conditions

Aortic Valve Stenosis Aortic Valve Disease Cardiovascular Diseases Heart Diseases Heart Valve Diseases Ventricular Outflow Obstruction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medizinische Universitat Wien Univ.Klinik f.Chirurgie, Vienna, Austria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion:

  • EuroSCORE of ≥ 15 %
  • Severe senile degenerative aortic valve stenosis
  • Symptomatic aortic valve stenosis
  • Informed consent
  • Compliance

Exclusion:

  • Logistic Euroscore > 40 %
  • Evidence of an acute myocardial infarction
  • Congenital unicuspid or congenital bicuspid valve/ non-calcified
  • Mixed aortic valve disease

Treatment and study plan

SAPIEN XT™ Transapical aortic valve replacement

Device

Transcatheter aortic valve implantation via the transapical approach

Other names: Sapien XT, Next generation Ascendra delivery system inclusive accessory

Primary outcomes

  1. Number of Deaths

    Time frame: 30 days

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

Secondary outcomes

  1. Number of Participants With a Stroke

    Time frame: 30-days

    Total Number of Participants with a Stroke.

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)

Important dates

Study start
2009
Primary completion
2011
Study completion
2016
First posted
Nov 11, 2010
Registry last updated
Nov 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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