Randomized Trial to Study the Efficacy and Adverse Effects of the Subcutaneous and Transvenous Implantable Cardioverter Defibrillator (ICD) in Patients With a Class I or IIa Indication for ICD Without an Indication for Pacing
Status: Unknown
Location: See all (38) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This randomized controlled trial will outline the advantages and disadvantages of the subcutaneous implantable cardioverter defibrillator (ICD) compared to the transvenous ICD.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Patients 18 years and older
• Patients with class I or IIa indication for ICD therapy according to the ACC/AHA/ESC 2006 Guidelines for Management of Patients With Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death
Locations
United States
Connecticut
Yale-New Haven Hospital
New Haven
Georgia
Emory University Hospital
Atlanta
Illinois
Northwestern Memorial Hospital
Chicago
The University of Chicago Medicine
Chicago
New Jersey
Englewood Hospital and Medical Center
Englewood
The Valley Hospital
Ridgewood
New York
Columbia University
New York
Mount SinaÏ Hospital
New York
Weill Cornell Medical College
New York
Ohio
Ohio State University Wexner Medical Center
Columbus
Other Locations
Denmark
Rigshospitalet
Copenhagen
Germany
Herzzentrum Dresden
Dresden
Universitätsklinikum Jena
Jena
Universtätsklinikum Kiel
Kiel
Herzzentrum Leipzig
Leipzig
Universitätsklinikum Mannheim
Mannheim
University Hospital Grosshadern
Munich
Universitätsklinikum Wurzburg
Wurzburg
Netherlands
Noordwest Hospital
Alkmaar
Flevoziekenhuis
Almere
Academic Medical Center - University of Amsterdam (AMC-UvA)
Amsterdam
Onze Lieve Vrouwe Gasthuis
Amsterdam
VU Medical Center
Amsterdam
Amphia Hospital
Breda
Catharina Hospital
Eindhoven
Medisch Spectrum Twente
Enschede
Medisch Centrum Leeuwarden
Leeuwarden
Maastricht University Medical Center
Maastricht
St. Antonius Hospital
Nieuwegein
Radboudumc
Nijmegen
ErasmusMC
Rotterdam
Isala Klinikum Zwolle
Zwolle
United Kingdom
Queen Elizabeth Hospital
Birmingham
Heart & Chest Hospital
Liverpool
Hammersmith Hospital
London
Saint Bartholomew's Hospital
London
St. Georges Hospital of London
London
Oxford University Hospitals NHS Trust
Oxford
Time Frame
Start Date: 2011-02
Completion Date: 2023-12
Participants
Target number of participants: 850
Treatments
Active_comparator: Subcutaneous ICD
Subcutaneous Implantable Cardioverter Defibrillator
Active_comparator: Transvenous ICD
Transvenous Implantable Cardioverter Defibrillator
Authors
M. A. Brouwer, R Weiss, J. W. Cheung, G. A. Upadhyay, M. F. El-Chami, J. F. Clancy, J. M. Dizon, H. Bonnemeier, S. Kääb, P. Nordbeck, M. Borggrefe, D. Nemirovsky, F. A. Bracke, T. R. Betts, Z. I. Whinnett, K. Vernooy, L. V. Boersma, J. van Opstal, N. R. Bijsterveld, P. Neuzil, P. D. Lambiase, Reinoud E Knops, E. R. Behr
Sponsors
Collaborators: Boston Scientific Corporation
Leads: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)