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

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis
• Interventions: Device: SAPIEN XT™ Transapical aortic valve replacement

• Registration Number: NCT01238835
• Lead Sponsor: Edwards Lifesciences

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2010-01-26
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-11
• Primary Completion: 2011-02
• Study Completion: 2016-03
• Results First Submitted: 2020-09-27
• Status Verified: 2020-10
• Results First Submitted QC: 2020-10-27
• Last Update Submitted: 2020-10-27
• Results First Posted: 2020-11-02
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TAVR-TA	SAPIEN XT™ Transapical aortic valve replacement	Transcatheter valve replacement with transapical access

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants With a Stroke	30-days	Total Number of Participants with a Stroke.

Trial Locations

Locations (20)

Herz-Und Gefasszentrum Bad Bevensen; 🇩🇪 Bad Bevensen, Germany

Medizinische Universitat Wien Univ.Klinik f.Chirurgie; 🇦🇹 Wien, Austria

Hôspital Bichat; 🇫🇷 Paris, France

Kerckhoff-Klinik; 🇩🇪 Bad Nauheim, Germany

Herz-und Diabeteszentrum NRW; 🇩🇪 Bad Oeynhausen, Germany

Herz-und-Gefass Klinik; 🇩🇪 Bad Neustadt An Der Saale, Germany

Schüchtermann-Klinik; 🇩🇪 Bad Rothenfelde, Germany

Heart Center University Cologne; 🇩🇪 Cologne, Germany

Herzzentrum Dresden GmbH; 🇩🇪 Dresden, Germany

University Clinic Erlangen; 🇩🇪 Erlangen, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Cardiac Surgery Karlsruhe; 🇩🇪 Karlsruhe, Germany

Heart Center Leipzig; 🇩🇪 Leipzig, Germany

German Heart Center Munich; 🇩🇪 Munich, Germany

University Hospital Munich-Grosshadern; 🇩🇪 Munich, Germany

Robert-Bosch-Krankenhaus; 🇩🇪 Stuttgart, Germany

King's College Hospital; 🇬🇧 London, United Kingdom

St. Thomas' Hospital - NHS Trust; 🇬🇧 London, United Kingdom

University Hospital Essen, West German Heart Center; 🇩🇪 Essen, Germany

Hospital Munich-Bogenhausen; 🇩🇪 Munich, Germany