NCT02163850View on ClinicalTrials.gov

Transcatheter Aortic Valve Replacement System Pivotal Trial

NAUnknownINTERVENTIONAL
Enrollment

878

Participants

Timeline

Start Date

June 30, 2015

Primary Completion Date

December 31, 2017

Study Completion Date

December 31, 2021

Conditions
Aortic Valve Stenosis
Interventions
DEVICE

Direct Flow Medical

Direct Flow Medical Transcatheter Aortic Valve Replacement System (TAVR)

DEVICE

Commercially Available

Medtronic CoreValve Transcatheter Aortic Valve Replacement System (TAVR) or Edwards SAPIEN Transcatheter Aortic Valve Replacement System (TAVR)

Trial Locations (3)

10032

RECRUITING

NewYork-Presbyterian / Columbia Univ., New York

22908

RECRUITING

University of Virginia Health System, Charlottesville

43214

RECRUITING

Ohio Health Riverside Methodist, Columbus

Sponsors
All Listed Sponsors
lead

Direct Flow Medical, Inc.

INDUSTRY