198
Participants
Start Date
December 31, 2007
Primary Completion Date
August 31, 2012
Study Completion Date
October 31, 2012
Ovatio VR 6250 or DR6550
"The study requires the implantation of locally approved material:~* A right ventricular defibrillation lead~* In case of use of a dual chamber ICD a right atrial pacing lead~* A single chamber or dual chamber ICD manufactured by SORIN Group. At begin of the study this will be OVATIO VR model 6250 and OVATIO DR model 6550. Any new devices of same type manufactured by SORIN Group which will become locally approved during the conduction of the trial can be used in the study.~Holter recording will be performed with a market approved recording system allowing high resolution ECG recording compatible with the analysis software for TVar."
Praxis Westend, Berlin
Easton Cardiology, Easton
Städt Klinikum Lüneburg, Lüneburg
Krankenhaus Reinbeck St Adolf-Stift, Reinbeck
ST. Adolf Stift; Medizinische Klinik, Reinbek
CMC - NorthEast, Charlotte
Piedmont Hospital, Atlanta
Helen Kelle Hospital, Sheffield
Evangelisches Krankenhaus, Düsseldorf
Evangelisches Krankhenhaus Düsseldorf, Düsseldorf
Northwest Ohio Cardiology Consultants, Toledo
Universitatsklinik Krankenanstalten Bergmannsheil, Bochum
Universitario La Fe, Valencia
Johannes Gutenberg-Universitat, Mainz
Kardiocentrum, Frankfurt
Bogenhausen Städt. Krankenhaus, München
Valley Regional Arrhytmia Center, Tarzana
Klinikum, Coburg
Landkrankhenhaus Coburg, Coburg
Universitätsklinikum Würzburg, Würzburg
Stafford M. Smith - Scranton Heart Institute, Clarks Green
Grey-Nuns Hospital, Edmonton
Hotel-Dieu du CHUM, Montreal
Laval UH, Ste Foy, Québec
St. Michael's Hospital, Toronto
Herz-und Diabeteszentrum NRW, Bad Oeynhausen
Medizinische Universitatsklinik, Bonn
Kardiocentrum Frankfurt, Klinik Rotes Kreuz, Frankfurt
Universitatklinikum Mainz, Mainz
Medizinische Klinik und Poliklinik I / kardiologie, Würzburg
Lead Sponsor
LivaNova
INDUSTRY