Study Type
Interventional - Device
ongoing
ATLAS S-ICD is a multi-centered, randomized, open-label, parallel group trial evaluating whether a subcutaneous ICD (S-ICD) reduces perioperative complications compared to a transvenous ICD (TV-ICD), using a composite safety outcome.
This study will recruit patients with a standard primary or secondary indication for an ICD who are eligible for either a TV-ICD or S-ICD. They will be randomized to receive either a TV-ICD (control arm) or an S-ICD (experimental arm).
Patients randomized to the S-ICD arm will receive a Boston Scientific Emblem device, or subsequent generation Boston Scientific sub-cutaneous ICD. Safety will be assessed by comparing a composite of safety parameters measured at 6 months following implant.
Patients will also be 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 will be measured at six months following ICD implantation, and will be 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 will include 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 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.
Darryl Leong
Scientist
Darryl Leong
Scientist
Darryl Leong is a Scientist at PHRI, Director of the McMaster University and Hamilton Health Sciences Cardio-Oncology Program, Associate Professor, Department of Medicine (Cardiology), McMaster University, and Staff Cardiologist at Hamilton Health Sciences. He has methodological expertise in clinical epidemiology and clinical trials, and content expertise in physical frailty, echocardiography, and cardio-oncology. His research is supported by the CIHR, and he has published more than 150 manuscripts including all the leading internal medical and cardiovascular journals.
He graduated from the University of Adelaide Medical School with Deans Listing and Honours for academic excellence, completed his cardiology training, Doctor of Philosophy, Master of Public Health, and Master of Biostatistics degrees at the University of Adelaide in Australia, and completed a post-doctorate fellowship in cardiovascular imaging at the Leiden University Medical Centre in The Netherlands, before re-locating to Canada.
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.
