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

Not Applicable

• Conditions: Aortic Valve Stenosis
• Interventions: Device: Replacement of the Aortic Stenotic Valve

• 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

Arm && Interventions

Group	Intervention	Description
Percutaneous Aortic Valve 18F System	Replacement of the Aortic Stenotic Valve	Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients with Severe Aortic Stenosis.

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)

St. Bartholomew's Hospital; 🇬🇧 London, United Kingdom

Clinique Pasteur; 🇫🇷 Toulouse, France

San Raffaele Hospital; 🇮🇹 Milan, Italy

University Hospital Bonn; 🇩🇪 Bonn, Germany

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

Centre hospitalier de Luxembourg; 🇱🇺 Luxembourg, Luxembourg

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

Azienda Ospedaliera Niguarda Ca Granda; 🇮🇹 Milan, Italy

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

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

Krankenhaus der Barmherzigen Brüder Trier; 🇩🇪 Trier, Germany

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