Avoid Transvenous Leads in Appropriate Subjects (ATLAS S-ICD)

The purpose of the study is to compare standard, single chamber transvenous ICD to sub-cutaneous ICD in occurrence of perioperative and long term device related complications and failed appropriate clinical shocks and arrhythmic death.

Study Overview

• Status: Completed
• Conditions: Ventricular Arrhythmia
• Intervention / Treatment: Device: Implantable Cardioverter Defibrillator

• Study Type: Interventional
• Enrollment (Actual): 544
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada
      • University of Calgary
    • Edmonton, Alberta, Canada
      • Mazankowski Alberta Heart Institute
  • British Columbia
    • Vancouver, British Columbia, Canada
      • St. Paul's Hospital
    • Victoria, British Columbia, Canada
      • Victoria Cardiac Arrhythmia Trials Inc.
  • Ontario
    • Hamilton, Ontario, Canada
      • Hamilton General Hospital
    • Newmarket, Ontario, Canada
      • Southlake Regional Health Centre
    • Ottawa, Ontario, Canada
      • University of Ottawa Heart Institute
    • Toronto, Ontario, Canada
      • St. Michael's Hospital
    • Toronto, Ontario, Canada
      • Sunnybrook Health Sciences Centre
    • Toronto, Ontario, Canada
      • Toronto General Hospital, University Health Network
  • Quebec
    • Laval, Quebec, Canada
      • IUCPQ-Universite Laval
    • Montreal, Quebec, Canada
      • Montreal Heart Institute
    • Montréal, Quebec, Canada
      • McGill University Health Centre
    • Sherbrooke, Quebec, Canada
      • Centre hospitalier universitaire de Sherbrooke (CHUS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria: patient must satisfy any ONE of the following two criteria:

1. Patient is ≥ 18 - 60 years old AND has a standard indication for ICD; OR

2. Patient is ≥ 18 years old AND has any one of the following present:

   • An inherited arrhythmia syndrome (i.e. Long QT, Brugada, ARVC, hypertrophic or dilated cardiomyopathy, early repolarization syndrome, idiopathic ventricular fibrillation, etc.)
   • Prior pacemaker or ICD removal for infection
   • Need for hemodialysis
   • Prior heart valve surgery (repair or replacement)
   • Chronic obstructive pulmonary disease (with FEV1 < 1.5 L)

Exclusion Criteria:

• Mechanical tricuspid valve
• Fontan repair
• Presence of an intra-cardiac shunt
• Known lack of upper extremity venous access
• Need for cardiac pacing for bradycardia indication
• PR interval of > 240 msec
• Patients with permanent pacemaker
• Clinical indication for biventricular pacing
• Patients unwilling to provide informed consent or comply with follow-up
• Pregnant at time of enrollment and implant
• Patients who currently have a ventricular assist device (i.e. LVAD)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Subcutaneous ICD; Patient will receive a subcutaneous implantable cardioverter defibrillator (Boston Scientific EMBLEM)	Device: Implantable Cardioverter Defibrillator; Patients will be randomized to receive either a subcutaneous or transvenous ICD.
Other: Transvenous ICD; Patient will receive a single-chamber, transvenous implantable cardioverter defibrillator (from any manufacturer) which as the capability for remote monitoring.	Device: Implantable Cardioverter Defibrillator; Patients will be randomized to receive either a subcutaneous or transvenous ICD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite of lead-related perioperative complications	This composite includes: 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.	6 months post-ICD implantation
Additional safety composite	This composite includes: Device-related infection requiring surgical revision; Significant wound hematoma (requiring evacuation or interruption of oral anticoagulation); Myocardial infarction; Stroke; Death;	6 months post-ICD implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late device-related complications	The following complications will be measured by their presence or absence; they will be presented as individual complications and also as a composite of late device-related complications: Lead dislodgement or fracture; or loss of adequate sensing or pacing; Device-related infection; Pericarditis or pericardial effusion; New severe tricuspid insufficiency; Ipsilateral upper extremity deep venous thrombosis; Need to revise dialysis access; Need to revise ICD or lead for any reason; Non-systemic embolism; Pulmonary embolism; Wound dehiscence or disjunction; Allergic reaction to ICD	Greater than 6 months post-ICD implantation
Total device-related complications	This is a composite of: all components of the primary and secondary safety outcomes, and late device-related complications.	Greater than 6 months post-ICD implantation
Occurrence of failed appropriate shock or arrhythmic death	Efficacy outcome	6 months post-ICD implantation
Hospital, emergency department or clinic visits for ICD therapy, device-related complications, arrhythmia or heart failure	Efficacy outcome. Hospital, emergency department or clinic visits for ICD therapy (shocks or anti-tachycardia pacing, both appropriate and inappropriate), device-related complications, arrhythmia or heart failure	6 months post-ICD implantation
Any inappropriate ICD therapy shock	Efficacy outcome	6 months post-ICD implantation
All-cause mortality	Efficacy outcome	6 months post-ICD implantation
Provincial healthcare payer health economics analysis	A formal health economics analysis will be completed as part of this study, using the perspective of a provincial healthcare payer. Procedural costs will be obtained from the Ontario schedule of benefits and the cost of device-implantation will be taken from existing, local case-costing data. The cost-effectiveness analysis will take into consideration any differences in survival, complication rates and resource utilization. Sensitivity analyses will be done, varying the price of the S-ICD, in order to generate cost-acceptability curves.	6 months post-ICD implantation
Patient Acceptance of ICD as measured by Florida Patient Acceptance Survey (FPAS)	Patient acceptance of ICD will be measured using the Florida Patient Acceptance Survey (FPAS).	1 month and 6 month post-ICD implantation
Patient Health Survey as measured by Short Form Health Survey (SF36)	Patient health will be assessed by a generic instrument, the Short Form Health Survey (SF36). This survey provides scores for each of the eight health domains and psychometrically-based physical component summary and mental component summary scores.	Baseline and 6 months post-ICD implantation

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Collaborators: Boston Scientific Corporation
• Investigators: Principal Investigator: Jeff Healey, MD, Population Health Research Institute; Principal Investigator: Blandine Mondesert, MD, Université de Montréal

Publications and helpful links

General Publications

• Mondesert B, Bashir J, Philippon F, Dubuc M, Amit G, Exner D, Joza J, Birnie DH, Lane C, Tsang B, Korley V, Spears D, Ling A, Djuric A, Crystal E, Hruczkowski T, Roux JF, Carroll S, Essebag V, Krahn AD, Healey JS. Rationale and design of the randomized prospective ATLAS study: Avoid Transvenous Leads in Appropriate Subjects. Am Heart J. 2019 Jan;207:1-9. doi: 10.1016/j.ahj.2018.09.008. Epub 2018 Oct 9.
• Healey JS, Krahn AD, Bashir J, Amit G, Philippon F, McIntyre WF, Tsang B, Joza J, Exner DV, Birnie DH, Sadek M, Leong DP, Sikkel M, Korley V, Sapp JL, Roux JF, Lee SF, Wong G, Djuric A, Spears D, Carroll S, Crystal E, Hruczkowski T, Connolly SJ, Mondesert B; ATLAS Investigators*. Perioperative Safety and Early Patient and Device Outcomes Among Subcutaneous Versus Transvenous Implantable Cardioverter Defibrillator Implantations : A Randomized, Multicenter Trial. Ann Intern Med. 2022 Nov 8. doi: 10.7326/M22-1566. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2017
• Primary Completion (Actual): January 31, 2022
• Study Completion (Actual): February 10, 2022

Study Registration Dates

• First Submitted: August 2, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimate): August 26, 2016

Study Record Updates

• Last Update Posted (Actual): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 26, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: implantable cardioverter defibrillator; subcutaneous ICD; transvenous ICD; inherited arrhythmia syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: ATLAS S-ICD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes