NCT01845285 - A Registry to Evaluate the Direct Flow Medical Transcatheter Aortic Valve System | Biotech Hunter

Enrollment

1,000

Participants

Timeline

Start Date

March 31, 2013

Primary Completion Date

December 31, 2016

Study Completion Date

December 31, 2019

Conditions

Aortic Valve Stenosis

Interventions

DEVICE

Aortic Valve Replacement

Transthoracic Echo (TTE),CT Scan (ECG triggered, contrast enhanced),Aorto-Iliac Angiogram,Peripheral Evaluation,Coronary Evaluation,12 lead ECG,Arrhythmia Assessment, New York Heart Association (NYHA) functional status, Modified Rankin Score Assessment (mRS) if symptomatic for stroke, Current Cardiac Medications, Transthoracic echo (TTE)

Trial Locations (2)

20162

RECRUITING

Ospedale Niguarda Ca' Granda, Milan

45138

RECRUITING

Elisabeth Krankenhaus, Essen