Study Type
Interventional - Device
completed
The objective of the SIMPLE trial was to test the hypothesis that use of an implantable cardioverter defibrillator (ICD) without induction of ventricular fibrillation is non-inferior to implantation with testing against the composite endpoint of ineffective first appropriate clinical shock or arrhythmic death.
Primary endpoint:
First occurrence of the composite of failed first appropriate clinical shock from the ICD or arrhythmic death.
Secondary endpoint:
Complication rate. All outcome events are adjudicated.
Study Design
Randomized, single blind (subject), active control, parallel group, non-inferiority
NO. of Countries
18
NO. of Sites
85
NO. of Participants
2500
Study Period
2009-2014
Sponsor
Boston Scientific
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.
