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
500
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.
Heather Beresh
Study Team Specialist
Heather Beresh
Study Team Specialist
Heather Beresh has worked at PHRI since May 2002, largely devoted to managing global, multi-centre clinical trials of antithrombotic therapies in patients with atrial fibrillation (AF). She started as research coordinator for the ACTIVE study evaluating dual antiplatelet therapy and angiotensin receptor blockers in patients with AF, then continued with oversight of the AVERROES open label extension trial evaluating a novel oral anticoagulant in the same population, and ARTESiA evaluating anticoagulant therapy in patients with subclinical AF.
After years as Associate Program Manager for the Heart Failure and Arrhythmia Program, managing networks such as C-SPIN, and on the ACT COVI-19 research program, Heather was made Study Team Specialist in 2021, to provide regulatory, country and site management expertise to the studies in the Global Health research team. She has as a Master’s degree in Medical Sciences from McMaster University.
