A Clinical Evaluation of the Durata or Optisure High Voltage Leads and Ellipse VR ICD Undergoing MRI, an IDE Study

NACompletedINTERVENTIONAL
Enrollment

227

Participants

Timeline

Start Date

May 31, 2016

Primary Completion Date

January 12, 2017

Study Completion Date

April 11, 2018

Conditions
Implantable Defibrillator User
Interventions
DEVICE

Ellipse VR ICD and Durata/Optisure lead

Non-diagnostic MRI Scan sequence of head and chest

Trial Locations (32)

Unknown

John C. Lincoln North Mountain Hospital, Phoenix

Central Cardiology, Bakersfield

Scripps Health, La Jolla

Florida Hospital, Orlando

Athens Regional Medical Center, Athens

Redmond Regional Medical Center, Rome

Prairie Education and Research Cooperative, Springfield

Parkview Research Center, Fort Wayne

Medical Consultants, Muncie

Massachusetts General Hospital, Boston

Sparrow Clinical Research Institute, Lansing

Providence Hospital, Southfield

Jackson Heart Clinic, Jackson

St. Francis, Roslyn

The Cleveland Clinic Foundation, Cleveland

Samaritan Heart & Vascular Institute, Corvallis

Saint Vincent Consultants in Cardiovascular Diseases, Erie

Pinnacle Health System, Harrisburg

Penn State Milton S. Hershey Medical Center, Hershey

Donald Guthrie Foundation for Education and Research, Sayre

Methodist University Hospital, Memphis

St. Thomas Hospital, Nashville

Baylor All Saints Medical Center at Fort Worth, Fort Worth

West Virginia University Hospital, Morgantown

Aurora Medical Group, Milwaukee

Cardiac Rhythm Specialists, S.C., Milwaukee

Semmelweis University, Budapest

Szpital Kliniczny Premienienia Panskiego, Poznan

American Heart of Poland SA, Tychy

Carint Scanmed Sp. z.o.o., Krakow

Hospital Universitario de Salamanca, Salamanca

Golden Jubilee National Hospital, Clydebank

Sponsors
All Listed Sponsors
lead

Abbott Medical Devices

INDUSTRY