500
Participants
Start Date
January 31, 2016
Primary Completion Date
April 30, 2017
Study Completion Date
May 4, 2018
ImageReady MR Conditional Defibrillation System
"ImageReady MR Conditional Defibrillation System Components:~Device Name Device Model Number Pulse Generators Phase I and II Phase II Only \* CRT-D (IS1/DF4/IS4) VR ICD (DF4) DR ( dual chamber) ICD (IS1/DF4) ORIGEN™ MINI ICD ORIGEN EL ICD ORIGEN X4 CRT INOGEN™ MINI ICD INOGEN EL ICD INOGEN X4 CRT DYNAGEN™ MINI ICD DYNAGEN EL ICD DYNAGEN X4 CRT-D AUTOGEN ™ MINI ICD\* AUTOGEN EL ICD\* AUTOGEN X4 CRT-D\* Right Atrial Leads and Accessories FINELINE™ II Sterox FINELINE II Sterox EZ Suture Sleeves for FINELINE II Leads INGEVITY™ MRI\* Suture Sleeve for INGEVITY MRI\* IS-1 Lead Port Plug 7145 Right Ventricular Leads and Accessories RELIANCE 4-FRONT™ (DF4)\* Suture Sleeve for RELIANCE 4-FRONT leads\*; ENDOTAK RELIANCE™ (DF4) Left Ventricular Leads and Accessories ACUITY™ X4 (IS4) Suture Sleeve for ACUITY X4 leads~\* May only be used internationally outside the US"
Cardiology Associates of Northeast Arkansas, Jonesboro
Heart Center Research, LLC, Huntsville
Huntington Memorial Hospital, Pasadena
University of California - San Diego-N, San Diego
John Muir Medical Center, Walnut Creek
Manatee Memorial Hospital, Bradenton
Lakeland Regional Medical Center, Lakeland
University Community Hospital, Tampa
Emory University Hospital, Atlanta
St. John's hospital, Springfield
St. Vincent's Hospital, Indianapolis
University of Iowa Hospitals and Clinics, Iowa City
Marquette General Hospital, Marquette
Centracare Heart and Vascular Center, Saint Cloud
HealthEast St. Joseph's Hospital, Saint Paul
North Mississippi Medical Center, Tupelo
Cox Health, Springfield
Northwell Health, New York
University of North Carolina Hospital, Chapel Hill
OhioHealth Research and Innovation Institute - Riverside Methodist Hospital, Columbus
The Toledo Hospital, Toledo
Providence St. Vincent Medical Center, Portland
Bryn Mawr Medical Specialists, Bryn Mawr
Thomas Jefferson University Hospital, Philadelphia
Rapid City Regional Hospital, Rapid City
St. Thomas Research Institute, LLC, Nashville
SouthEast Texas Clinical Research Center, Beaumont
University of Texas Houston Health Science Center, The Woodlands
Trinity Mother Frances Health System, Tyler
University of Utah Hospital and Clinics, Salt Lake City
Sentara Norfolk General Hospital, Norfolk
Virginia Commonwealth University Health System, Richmond
Providence Regional Medical Center Everett, Everett
PeaceHealth Southwest Medical, Vancouver
Academisch Ziekenhuis Middelheim, Antwerp
Deutsches Herzzentrum Berlin, Berlin
Medizinische Hochschule Hannover MHH, Hanover
Klinikum Magdeburg, Magdeburg
Prince of Wales Hospital, Hong Kong
Queen Mary Hospital, Hong Kong
Rambam Medical Center, Haifa
Soroka MC, Petah Tikva
Tel Aviv Sourasky Medical Center, Tel Aviv
Hadassah Hebrew University Medical Center, Tel Litwinsky
Fondazione di Ricerca e Cura 'Giovanni Paolo II', Campobasso
Azienda Ospedaliera Universitaria Federico II, Napoli
Azienda Ospedaliera San Camillo-Forlanini, Roma
Ospedale S.G. Calibita Fatebenefratelli - Isola Tiberina, Roma
Ospedale san giovanni calibita, Roma
Policlinico Casilino, Roma
Osp. S. Maria Della Misericordia, Udine
Institut Jantung Negara, Kuala Lumpur
University of Malaya Medical Centre, Kuala Lumpur
Hospital Clinic de Barcelona, Barcelona
Heart and Chest Hospital, Liverpool
Guys and St. Thomas NHS Foundation Trust, London
Freeman Hospital, Newcastle
Lead Sponsor
Boston Scientific Corporation
INDUSTRY