Study Type
Interventional - Device
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:
A secondary 6-month safety composite will include the following, in addition to the above complications:
Interventional - Device
Multi-center randomized open-label parallel group
1
14
500
2017 - 2022
PHRI
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