Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
544 participants
INTERVENTIONAL
2017-02-22
2022-02-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Subcutaneous ICD
Patient will receive a subcutaneous implantable cardioverter defibrillator (Boston Scientific EMBLEM)
Implantable Cardioverter Defibrillator
Patients will be randomized to receive either a subcutaneous or transvenous ICD.
Transvenous ICD
Patient will receive a single-chamber, transvenous implantable cardioverter defibrillator (from any manufacturer) which as the capability for remote monitoring.
Implantable Cardioverter Defibrillator
Patients will be randomized to receive either a subcutaneous or transvenous ICD.
Interventions
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Implantable Cardioverter Defibrillator
Patients will be randomized to receive either a subcutaneous or transvenous ICD.
Eligibility Criteria
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Inclusion Criteria
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
* 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)
18 Years
ALL
No
Sponsors
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Boston Scientific Corporation
INDUSTRY
Population Health Research Institute
OTHER
Responsible Party
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Principal Investigators
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Jeff Healey, MD
Role: PRINCIPAL_INVESTIGATOR
Population Health Research Institute
Blandine Mondesert, MD
Role: PRINCIPAL_INVESTIGATOR
Université de Montréal
Locations
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University of Calgary
Calgary, Alberta, Canada
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
Victoria Cardiac Arrhythmia Trials Inc.
Victoria, British Columbia, Canada
Hamilton General Hospital
Hamilton, Ontario, Canada
Southlake Regional Health Centre
Newmarket, Ontario, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Toronto General Hospital, University Health Network
Toronto, Ontario, Canada
IUCPQ-Universite Laval
Laval, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Montreal Heart Institute
Montreal, Quebec, Canada
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
Sherbrooke, Quebec, Canada
Countries
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References
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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.
Carroll SL, Mondesert B, Krahn AD, Bashir JG, Fisher K, Nair K, Healey JS. Device-specific quality of life: results from the ATLAS trial-avoid transvenous leads in appropriate subjects. Eur J Cardiovasc Nurs. 2024 Dec 16;23(8):877-885. doi: 10.1093/eurjcn/zvae067.
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 Dec;175(12):1658-1665. doi: 10.7326/M22-1566. Epub 2022 Nov 8.
Other Identifiers
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ATLAS S-ICD
Identifier Type: -
Identifier Source: org_study_id
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