Interventional - Drug
To reduce infection after pacemaker or ICD surgery, antibiotics are used but the ideal amount and duration is unknown. Many different antibiotic strategies are used in Canada but no comparative effectiveness studies had been performed.
We did not know if the standard single dose of intravenous antibiotic is enough or if extra doses of different antibiotics before, during and after surgery help to reduce infection. Pacemaker and ICD procedures are delivered at high volume specialized centres following Standard Operating Procedures.
Because of this systemization of care, comparative effectiveness testing to improve care was tested in the systems in which they will be used. PADIT tested whether single antibiotics or additional antibiotics reduce infection best by randomizing centres, not patients, to one antibiotic strategy or another. Centres were randomized to one therapy and then cross over to the next after six months.
At one year, they were randomized again and then crossed over for a final time at 18 months. All patients at the centre received a pacemaker of ICD will receive that strategy during the study.
One-year post-implant sites to review their hospital records to determine if any endpoints were met.
Co-Principal Investigator on this study was Andrew Krahn, Professor, Head of Division of Cardiology, Department of Medicine, University of British Columbia.
Interventional - Drug
Randomized, Cluster Crossover.
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.
Study Team Specialist
Heather Beresh has worked at PHRI since May 2002, largely devoted to managing global, multi-centre clinical trials of antithrombotic therapies in patients with atrial fibrillation (AF). She started as research coordinator for the ACTIVE study evaluating dual antiplatelet therapy and angiotensin receptor blockers in patients with AF, then continued with oversight of the AVERROES open label extension trial evaluating a novel oral anticoagulant in the same population, and ARTESiA evaluating anticoagulant therapy in patients with subclinical AF.
After years as Associate Program Manager for the Heart Failure and Arrhythmia Program, managing networks such as C-SPIN, and on the ACT COVI-19 research program, Heather was made Study Team Specialist in 2021, to provide regulatory, country and site management expertise to the studies in the Global Health research team. She has as a Master’s degree in Medical Sciences from McMaster University.
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