Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis

Not Applicable

• Conditions: Aortic Valve Stenosis

• Registration Number: NCT01475799
• Lead Sponsor: Direct Flow Medical, Inc.

Brief Summary

The purpose of the study is to determine the safety and performance of the Direct Flow Medical study valve and delivery procedure.

Detailed Description

Prospective, multicenter, non-randomized clinical trial of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the treatment of severe aortic stenosis

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-11-17
• Study First Posted: 2011-11-21
• Primary Completion: 2014-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-31
• Last Update Posted: 2016-11-01
• Study Completion: 2019-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Freedom from all-cause mortality from procedure to 30 days	Procedure to 30 days

Secondary Outcome Measures

Name	Time	Method
Device Success at procedure completion	At procedure completion	Device success is assessed at the completion of the study procedure based on TEE

Trial Locations

Locations (12)

L'Institut Hospitalier Jacques Cartier; 🇫🇷 Massy, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Vivantes Klinikum im Friedrichshain; 🇩🇪 Berlin, DE, Germany

University Hospital Bonn; 🇩🇪 Bonn, Germany

Elisabeth-Krankenhaus Essen, GmbH; 🇩🇪 Essen, Germany

Medical Care Center, Prof Mathey, Prof Schofer; 🇩🇪 Hamburg, Germany

Krankenhaus der Barmherzigen Brüder Trier; 🇩🇪 Trier, Germany

San Raffaele Hospital; 🇮🇹 Milan, Italy

Azienda Ospedaliera Niguarda Ca Granda; 🇮🇹 Milan, Italy

Centre hospitalier de Luxembourg; 🇱🇺 Luxembourg, Luxembourg

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