Study Type
Observational
completed
To systematically collect and quantify characteristics of the ICD (Implantable Cardioverter Defibrillator) implant procedures and defibrillator testing (DF) procedures in Canadian hospitals and evaluate the short term clinical and economic outcomes.
Quantify the following characteristics of the ICD implant procedures and DF testing in Canadian hospitals and evaluate the short term clinical and economic outcomes. 1. Types of defibrillation testing procedures in current use in Canada. 2. Rate of use and non-use of defibrillation testing. 3. Medical indications for non-use of defibrillation testing. 4. Rate of successful testing of first lead configuration used. 5. Rates and types of complications from defibrillation testing. 6. Costs of implant procedures and the costs related to defibrillation testing. 7. Short-term outcomes of patients with different types of implant procedures.
Study Design
Observational
NO. of Countries
1
NO. of Sites
13
NO. of Participants
340
Study Period
2005 - 2009
Sponsor
PHRI
Stuart Connolly
Senior Scientist
Stuart Connolly
Senior Scientist
Stuart Connolly is a Professor of Medicine at McMaster University and a cardiac electrophysiologist at Hamilton Health Sciences. He became a faculty member at McMaster University in 1983 and was awarded a full professorship in 1994. He was also appointed as the inaugural holder of the Salim Yusuf Chair in Cardiology at McMaster University.
He has published more than 270 scientific articles in the field, and is currently a member of the editorial boards for a number of prominent cardiology journals, including Heart, the American Heart Journal and the Journal of Pacing and Electrophysiology. His main research interests are focused on the evaluation of treatments for heart rhythm disorders. His academic career has been largely devoted to the design and execution of controlled clinical trials in this area.
He holds a Masters degree from Fordham University, New York, and an MD from McGill University in Montreal. He received his specialist training in cardiology at the University of Toronto and at Stanford University.
Jeff Healey
Senior Scientist
Jeff Healey
Senior Scientist
Jeff Healey is a Senior Scientist in the Arrhythmia and Heart Failure research program at PHRI, an Associate Professor, Medicine, McMaster University, and Director of Arrhythmia Services at Hamilton Health Sciences. His research involves conducting RCTs and large registries in the fields of atrial fibrillation and cardiac devices. He was the lead author of the SIMPLE trial, published in the Lancet in 2015, which demonstrated that implantable defibrillators could be safely inserted without performing intra-operative defibrillation testing.
He was the lead author of the ASSERT trial, published in New England Journal of Medicine in 2012, demonstrating the increased stroke risk associated with sub-clinical atrial fibrillation detected by pacemakers. Thomson-Reuters recognized ASSERT as the 38th most-cited scientific publication in 2012 (#16 in Medicine).
He was principal investigator and chair of the Canadian Stroke Prevention Intervention Network (CSPIN), a ten-year network grant funded by the Canadian Institutes of Health Research, The Heart and Stroke Foundation of Canada and Industry. He is the past co-chair of the Canadian Cardiovascular Society’s Atrial Fibrillation Guidelines Committee. Jeff has published more than 185 manuscripts.
Ellison Themeles
Associate Program Manager
Ellison Themeles
Associate Program Manager
Ellison Themeles’ experience includes more than 20 years in the conduct, execution and management of large, international clinical trials involving both medical devices and pharmaceutical agents in the area of cardiovascular disease and arrhythmias.
She holds a Bachelor of Arts degree in Gerontology and Sociology, and a Master of Science Degree in Health Research Methodology, from McMaster University.
