Study Type
Interventional - Device
completed
ATLAS S-ICD was a multi-centered, randomized, open-label, parallel group trial evaluating whether a subcutaneous ICD (S-ICD) reduced perioperative complications compared to a transvenous ICD (TV-ICD), using a composite safety outcome.
This study recruited patients with a standard primary or secondary indication for an ICD who were eligible for either a TV-ICD or S-ICD. They were randomized to receive either a TV-ICD (control arm) or an S-ICD (experimental arm).
Patients randomized to the S-ICD arm received a Boston Scientific Emblem device, or subsequent generation Boston Scientific sub-cutaneous ICD. Safety was assessed by comparing a composite of safety parameters measured at 6 months following implant.
Patients were also followed for between 12 and 48 months to measure: late device-related complications; mortality (total and arrhythmic death); and the rate and success of appropriate ICD therapies.
Primary endpoint:
The primary endpoint was measured at six months following ICD implantation, and was a composite of lead-related perioperative complications, including:
- Hemothorax or pneumothorax
- Cardiac perforation
- Tamponade
- Pericardial effusion or pericarditis
- Lead dislodgement or loss of pacing/sensing requiring revision
- New moderate-severe or severe tricuspid insufficiency (3+ or 4+)
- Ipsilateral upper extremity deep venous thrombosis
A secondary 6-month safety composite included the following, in addition to the above complications:
- Device-related infection requiring surgical revision
- Significant wound hematoma (requiring evacuation or interruption of oral anticoagulation)
- Myocardial infarction
- Stroke
- Death
Study Design
Multi-center randomized open-label parallel group
NO. of Countries
1
NO. of Sites
14
NO. of Participants
544
Study Period
2017 - 2022
Sponsor
PHRI
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.
Darryl Leong
Senior Scientist
Darryl Leong
Senior Scientist
Leong’s clinical interests include cardio-oncology, frailty, multi-morbidity, and echocardiography. He is the Director of the McMaster University and Hamilton Health Sciences Cardio-Oncology Program. Leong graduated from the University of Adelaide Medical School with Deans Listing and Honours for academic excellence in 2000. He completed his cardiology training, Doctor of Philosophy, Master of Public Health, and Master of Biostatistics degrees at the University of Adelaide, Australia. He has completed a fellowship in cardiovascular imaging at the Leiden University Medical Centre, the Netherlands, before relocating to Canada.
Leong is an Associate Professor in the Division of Cardiology, Department of Medicine, at McMaster University and Hamilton Health Sciences. His research is supported by the Canadian Institutes of Health Research, Canadian Cancer Society, and the United States Department of Defense, among others. He has published approximately 200 manuscripts, including leading publications in the Lancet and New England Journal of Medicine as well as top cardiovascular journals. He is a Clinician Scientist of the Heart and Stroke Foundation of Canada and has received the Clive Kearon Mid-Career Award from McMaster University. Additionally, he serves as the Director of the Internal Medicine Resident Research Program and the Cardio-Oncology Program at McMaster University.
Tara McCready
Program Director
Tara McCready
Program Director
Tara McCready, PhD, oversees a variety of collaborative programs at PHRI, and serves as Project Manager for PHRI research studies and registries.
She was recruited to PHRI as a Program Director for the Canadian Network and Centre for Trials Internationally (CANNeCTIN), a national network funded by the CIHR/CFI Clinical Research Initiative program to improve the prevention and treatment of cardiac and vascular diseases and diabetes.
Previously the Executive Director of the Canadian Maternal, Infant, Child and Youth Research Network, Tara holds a PhD in Biochemistry and a MBA in Technology Commercialization from the University of Alberta.
Boston Scientific
Recorded webinar held by BSC: Jeff Healey discusses results of ATLAS S-ICD, June 21, 2022
