Study Type
Interventional - Device
completed
The objective of the ASSERT study was to evaluate the hypothesis among patients with a standard indication for pacing and no previous history of atrial fibrillation (AF), detection of AHRE predicts an increased risk of stroke and systemic embolism. The second hypothesis to be tested is that overdrive atrial pacing with the AF suppression algorithm will reduce the risk of symptomatic AF in patients with standard indication for pacing and no previous history of AF.
Primary Outcomes:
Asymptomatic AF Stroke Evaluation, first occurrence of either component of the composite of:
1. Ischemic Stroke
2. Non-CNS systemic embolism. Trial of AF Suppression Algorithm, Symptomatic or asymptomatic atrial tachyarrhythmia (>6mins) documented by 12 lead ECG, or surface ECG rhythm strip.
Secondary Outcomes:
1. Symptomatic atrial tachyarrhythmia (>6mins) documented by 12 lead ECG, or surface ECG rhythm strip.
2. Symptomatic or asymptomatic atrial tachyarrhythmia (>6mins) documented by 12 lead ECG, surface ECG rhythm strip or pacemaker telemetry (EGMs only).
3. Total cardiovascular events (composite of stroke, myocardial infarction, vascular death, systemic embolism or admission to hospital for heart failure). 4. AF Burden as derived from the pacemaker telemetry.
5. Major bleed.
Study Design
Cohort study
NO. of Countries
23
NO. of Sites
136
NO. of Participants
2580
Study Period
2007 - 2011
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.
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.
completed
ASSERT II
Arrhythmia & Heart Failure
Patients with known cardiovascular risk factors and left atrial enlargement, but without prior atrial fibrillation...
completed
ASSERT III
Arrhythmia & Heart Failure
In the ASSERT study, subclinical Atrial Fibrillation (SCAF) detected by a pacemaker over a prolonged...
