Study Type
Interventional - Device
completed
In the ASSERT study, subclinical Atrial Fibrillation (SCAF) detected by a pacemaker over a prolonged period of time was shown to increase a patient’s risk of stroke by almost three-fold. Less evasive techniques using external loop recorders now affords the possibility for longer term monitoring and the possibility of diagnosing a substantial portion of this sub-clinical AF.
Patients most at risk for developing AF are those who are elderly and have a history of hypertension. These patients were invited to participate in the ASSERT III study where they were monitored over a 60-day period for the development of subclinical AF via an external loop recorder using automatic algorithms for AF detection. The device automatically recorded and transmitted ECGs through a BlackBerry smartphone.
The primary hypothesis was that among this elderly population with hypertension and a least one other risk factor for AF, the monitoring will detect AF in at least 10% of patients who would be potential candidates for anticoagulant therapy.
Study Design
Cohort study
NO. of Countries
1
NO. of Sites
8
NO. of Participants
129
Study Period
2014 - 2015
Sponsor
PHRI
Stuart Connolly
Stuart Connolly
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 Cardiologist/Electrophysiologist and Professor of Medicine at McMaster University. He is Yusuf Chair and Director of Cardiology at McMaster University. He is the chair of the Canadian Stroke Prevention and Intervention Network (CSPIN) and past chair of the Canadian Atrial Fibrillation guidelines committee. He is also on the steering committee of the international AF Screen organization.
Healey was the lead author of the ASSERT trial that demonstrated the increased stroke risk associated with sub-clinical atrial fibrillation (New England Journal of Medicine 2012), and the principal investigator of the ARTESIA trial, which demonstrated that anticoagulation with apixaban reduced the risk of stroke in patients with sub-clinical atrial fibrillation New England Journal of Medicine 2023). He is also the principal investigator of the LAAOS-4 trial, evaluating the role of left atrial appendage occlusion on top of NOAC therapy for prevention of stroke in high-risk individuals with atrial fibrillation.
Bristol-Myers Squibb
New Investigator Fund
BMS/Pfizer grant-in-aid
m-Health Solutions grant-in-aid
AF Screen International Collaboration
completed
ASSERT
Arrhythmia & Heart Failure
The objective of the ASSERT study was to evaluate the hypothesis among patients with a...
completed
ASSERT II
Arrhythmia & Heart Failure
Patients with known cardiovascular risk factors and left atrial enlargement, but without prior atrial fibrillation...
