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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
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Study Type

Interventional - Device

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

Boston Scientific

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