Interventional - Device
Patients with known cardiovascular risk factors and left atrial enlargement, but without prior atrial fibrillation (AF) had a continuous ECG monitor implanted (St. Jude Medical Implantable Cardiac Monitor) to detect the incidence of sub-clinical AF and study the relationship between sub-clinical AF and left atrial volume and other potential predictors.
Patients were recruited from a variety of clinical settings (heart failure clinics, stroke clinics, diabetes clinics, pre-op and pre-catheterization clinics) and, in many cases, the implant can be done in conjunction with a planned surgery or procedure.
All patients were followed at one, three, six and nine months, and then underwent a final visit at 18 months of follow-up or after the last patient was followed for nine months (whichever came first).
Co-Principal Investigator on ASSET II was Marco Alings, of the Amphia Ziekenhuis, Breda, the Netherlands.
Interventional - Device
2012 - 2016
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 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.
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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