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
HRS2022 presentation - download PDF HRS2023 presentation - download PDF
Study Type

Interventional - Device

Study Design

Multi-center randomized open-label parallel group

NO. of Countries


NO. of Sites


NO. of Participants


Study Period

2017 - 2022



Boston Scientific

Recorded webinar held by BSC: Jeff Healey discusses results of ATLAS S-ICD, June 21, 2022

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