Avoid Transvenous Leads in Appropriate Subjects
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.
Multi-center randomized open-label parallel group clinical trial
The primary endpoint will be measured at 6 months following ICD implantation, and will be a composite of lead-related perioperative complications, including:
A secondary 6-month safety composite will include the following, in addition to the above complications:
Jeff Healey, Blandine Mondésert
Angie Djuric (Jr RC), Andrea Thornton (Sr RC)
Boston Scientific (grant-in-aid)