Research

ATLAS S-ICD

Official Title

Avoid Transvenous Leads in Appropriate Subjects

Status

Ongoing

Overview

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.

Study Design

Multi-center randomized open-label parallel group clinical trial

Primary Endpoint

The primary endpoint will be measured at 6 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

Number of Patients

500

Number of Sites

14

Number of Countries

1

Study Period

2017-2022

Principal Investigator

Jeff Healey, Blandine Mondésert

Program Manager

Heather Beresh

Research Coordinator

Angie Djuric (Jr RC), Andrea Thornton (Sr RC)

Collaborators

Boston Scientific (grant-in-aid)