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

NCT ID: NCT00820599

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

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

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"), its transfemoral delivery system, and crimper accessories. The trial includes a premarket confirmatory cohort to evaluate the system performance as well as a Post Market Clinical Follow-up phase involving expanded enrollment and long-term follow-up of all patients to evaluate valve performance out to 5 years.

Detailed Description

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Edwards Lifesciences obtained CE marking authorization for transfemoral delivery / implantation of the Edwards SAPIEN™ transcatheter heart valve (model 9000TFX) using the RetroFlex™ delivery system in August 2007 and introduced these devices for commercial distribution in the European Economic Area (EEA) in October 2007.

Clinical Sites: Up to 11 sites in Europe

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

Transaortic Valve Replacement

Group Type EXPERIMENTAL

Sapien XT™ transcatheter heart valve and delivery system

Intervention Type DEVICE

Interventions

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Sapien XT™ transcatheter heart valve and delivery system

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients must have co-morbidities such that the surgeon (Co Investigator) and interventional cardiologist (Principal Investigator) concur that the predicted risk of operative mortality is \> 15% with a minimum STS Risk Calculator score of ≥ 10 and/or Logistic EuroSCORE of \> 20%.
2. Patient is symptomatic from his/her aortic valve stenosis, as demonstrated by NYHA Functional Class II or greater.
3. The subject or the subject's legal representative has been informed of the nature of the study, agrees to its provisions and has provided a written informed consent that has been approved by the reviewing Ethics Committee (EC) of the respective clinical site.
4. Subject is willing to comply with specified follow up evaluations, including possible coronary angiography and transesophageal echocardiography.
5. The subject and the treating physician agree that the subject will return for all required post-procedure follow-up visits.

Exclusion Criteria

1. Aortic valve is a congenital unicuspid or bicuspid valve, or is non-calcified.
2. Mixed aortic valve disease (aortic stenosis and aortic regurgitation with predominant aortic regurgitation \>3+).
3. Any therapeutic invasive cardiac procedure, other than BAV, performed within 30 days of the index procedure (or 6 months if the procedure was a drug eluting coronary stent implantation).
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. Stefan Sack

Role: STUDY_DIRECTOR

Cardiology Clinic of Schwabing Clinic

Isabelle Fourthin

Role: STUDY_DIRECTOR

Edwards Lifesciences SA

Locations

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Ornze Lieve Vrouwziekenhuis (OLVZ) Aalst

Aalst, , Belgium

Site Status

Institut Hospitalier Jacques Cartier

Massy, , France

Site Status

Hospital Bichat Claude Bernard

Paris, , France

Site Status

CHU Hospital Charles Nicolle

Rouen, , France

Site Status

Clinique Pasteur

Toulouse, , France

Site Status

Hamburg University Cardiovascular Center

Hamburg, , Germany

Site Status

City Clinics Karlsruhe

Karlsruhe, , Germany

Site Status

Heart Center Leipzig

Leipzig, , Germany

Site Status

Schwabing Clinic

Munich, , Germany

Site Status

St. Thomas' Hospital - NHS Trust

London, , United Kingdom

Site Status

Kings College Hospital - NHS Trust

London, , United Kingdom

Site Status

Countries

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Belgium France Germany United Kingdom

Other Identifiers

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2008-04

Identifier Type: -

Identifier Source: org_study_id