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

Primary Purpose

Aortic Valve Stenosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
SAPIEN XT™ Transapical aortic valve replacement
Sponsored by
Edwards Lifesciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Sapien XT Valve, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transapical, Transcatheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medizinische Universitat Wien Univ.Klinik f.Chirurgie
  • Hôspital Bichat
  • Herz-Und Gefasszentrum Bad Bevensen
  • Kerckhoff-Klinik
  • Herz-und-Gefass Klinik
  • Herz-und Diabeteszentrum NRW
  • Schüchtermann-Klinik
  • Heart Center University Cologne
  • Herzzentrum Dresden GmbH
  • University Clinic Erlangen
  • University Hospital Essen, West German Heart Center
  • Universitätsklinikum Hamburg-Eppendorf
  • Cardiac Surgery Karlsruhe
  • Heart Center Leipzig
  • German Heart Center Munich
  • University Hospital Munich-Grosshadern
  • Hospital Munich-Bogenhausen
  • Robert-Bosch-Krankenhaus
  • St. Thomas' Hospital - NHS Trust
  • King's College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TAVR-TA

Arm Description

Transcatheter valve replacement with transapical access

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants With a Stroke
Total Number of Participants with a Stroke.

Full Information

First Posted
January 26, 2010
Last Updated
October 27, 2020
Sponsor
Edwards Lifesciences
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1. Study Identification

Unique Protocol Identification Number
NCT01238835
Brief Title
PREVAIL-TA: Placement of Aortic Balloon Expandable Transcatheter Valves Trial (Europe)
Official Title
Placement of AoRtic Balloon Expandable Transcatheter VAlves TrIaL (TransApical)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 2009 (Actual)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Edwards Lifesciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis
Keywords
Sapien XT Valve, Valvular Heart Disease, Aortic Stenosis, Heart Valve Therapy, Transapical, Transcatheter

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAVR-TA
Arm Type
Experimental
Arm Description
Transcatheter valve replacement with transapical access
Intervention Type
Device
Intervention Name(s)
SAPIEN XT™ Transapical aortic valve replacement
Other Intervention Name(s)
Sapien XT, Next generation Ascendra delivery system inclusive accessory
Intervention Description
Transcatheter aortic valve implantation via the transapical approach
Primary Outcome Measure Information:
Title
Number of Deaths
Description
Number of death at 30-days from the index procedure.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Number of Participants With a Stroke
Description
Total Number of Participants with a Stroke.
Time Frame
30-days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Thomas Walther
Organizational Affiliation
Kerckhoff Klinik
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dr. Olaf Wendler
Organizational Affiliation
King's College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medizinische Universitat Wien Univ.Klinik f.Chirurgie
City
Wien
ZIP/Postal Code
1019
Country
Austria
Facility Name
Hôspital Bichat
City
Paris
ZIP/Postal Code
75018
Country
France
Facility Name
Herz-Und Gefasszentrum Bad Bevensen
City
Bad Bevensen
ZIP/Postal Code
29549
Country
Germany
Facility Name
Kerckhoff-Klinik
City
Bad Nauheim
ZIP/Postal Code
61231
Country
Germany
Facility Name
Herz-und-Gefass Klinik
City
Bad Neustadt An Der Saale
ZIP/Postal Code
97616
Country
Germany
Facility Name
Herz-und Diabeteszentrum NRW
City
Bad Oeynhausen
ZIP/Postal Code
32545
Country
Germany
Facility Name
Schüchtermann-Klinik
City
Bad Rothenfelde
ZIP/Postal Code
49214
Country
Germany
Facility Name
Heart Center University Cologne
City
Cologne
ZIP/Postal Code
50924
Country
Germany
Facility Name
Herzzentrum Dresden GmbH
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
University Clinic Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
University Hospital Essen, West German Heart Center
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Cardiac Surgery Karlsruhe
City
Karlsruhe
ZIP/Postal Code
76185
Country
Germany
Facility Name
Heart Center Leipzig
City
Leipzig
ZIP/Postal Code
04829
Country
Germany
Facility Name
German Heart Center Munich
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
University Hospital Munich-Grosshadern
City
Munich
ZIP/Postal Code
81377
Country
Germany
Facility Name
Hospital Munich-Bogenhausen
City
Munich
ZIP/Postal Code
81925
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
St. Thomas' Hospital - NHS Trust
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Facility Name
King's College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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

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