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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous ICD | Other | Patient will receive a subcutaneous implantable cardioverter defibrillator (Boston Scientific EMBLEM) |
|
| Transvenous ICD | Other | Patient will receive a single-chamber, transvenous implantable cardioverter defibrillator (from any manufacturer) which as the capability for remote monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantable Cardioverter Defibrillator | Device | Patients will be randomized to receive either a subcutaneous or transvenous ICD. |
|
| 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 |
| 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:
|
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Inclusion Criteria: patient must satisfy any ONE of the following two criteria:
Patient is ≥ 18 - 60 years old AND has a standard indication for ICD; OR
Patient is ≥ 18 years old AND has any one of the following present:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Healey, MD | Population Health Research Institute | Principal Investigator |
| Blandine Mondesert, MD | Université de Montréal | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | Canada | |||
| Mazankowski Alberta Heart Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30399474 | Background | 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. | |
| 38695087 |
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| ID | Term |
|---|---|
| D017147 | Defibrillators, Implantable |
| ID | Term |
|---|---|
| D047548 | Defibrillators |
| D004566 | Electrodes |
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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| 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 |
| 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 |
| Derived |
| 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. |
| 36343346 | Derived | 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. |
| D004567 |
| Electrodes, Implanted |
| D019736 | Prostheses and Implants |