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

NCT ID: NCT01238835

Last Updated: 2020-11-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Aortic Valve Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAVR-TA

Transcatheter valve replacement with transapical access

Group Type EXPERIMENTAL

SAPIEN XT™ Transapical aortic valve replacement

Intervention Type DEVICE

Transcatheter aortic valve implantation via the transapical approach

Interventions

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SAPIEN XT™ Transapical aortic valve replacement

Transcatheter aortic valve implantation via the transapical approach

Intervention Type DEVICE

Other Intervention Names

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Sapien XT Next generation Ascendra delivery system inclusive accessory

Eligibility Criteria

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Inclusion Criteria

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Edwards Lifesciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof. Dr. Thomas Walther

Role: PRINCIPAL_INVESTIGATOR

Kerckhoff Klinik

Dr. Olaf Wendler

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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Medizinische Universitat Wien Univ.Klinik f.Chirurgie

Vienna, , Austria

Site Status

Hôspital Bichat

Paris, , France

Site Status

Herz-Und Gefasszentrum Bad Bevensen

Bad Bevensen, , Germany

Site Status

Kerckhoff-Klinik

Bad Nauheim, , Germany

Site Status

Herz-und-Gefass Klinik

Bad Neustadt an der Saale, , Germany

Site Status

Herz-und Diabeteszentrum NRW

Bad Oeynhausen, , Germany

Site Status

Schüchtermann-Klinik

Bad Rothenfelde, , Germany

Site Status

Heart Center University Cologne

Cologne, , Germany

Site Status

Herzzentrum Dresden GmbH

Dresden, , Germany

Site Status

University Clinic Erlangen

Erlangen, , Germany

Site Status

University Hospital Essen, West German Heart Center

Essen, , Germany

Site Status

Universitätsklinikum Hamburg-Eppendorf

Hamburg, , Germany

Site Status

Cardiac Surgery Karlsruhe

Karlsruhe, , Germany

Site Status

Heart Center Leipzig

Leipzig, , Germany

Site Status

German Heart Center Munich

Munich, , Germany

Site Status

University Hospital Munich-Grosshadern

Munich, , Germany

Site Status

Hospital Munich-Bogenhausen

Munich, , Germany

Site Status

Robert-Bosch-Krankenhaus

Stuttgart, , Germany

Site Status

St. Thomas' Hospital - NHS Trust

London, , United Kingdom

Site Status

King's College Hospital

London, , United Kingdom

Site Status

Countries

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Austria France Germany United Kingdom

Other Identifiers

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2009-06

Identifier Type: -

Identifier Source: org_study_id