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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
544
Patients will be randomized to receive either a subcutaneous or transvenous ICD.
University of Calgary
Calgary, Alberta, Canada
Mazankowski Alberta Heart Institute
Edmonton, Alberta, Canada
St. Paul's Hospital
Vancouver, British Columbia, Canada
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.
Time frame: 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;
Time frame: 6 months post-ICD implantation
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
Time frame: 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.
Time frame: Greater than 6 months post-ICD implantation
Occurrence of failed appropriate shock or arrhythmic death
Efficacy outcome
Time frame: 6 months post-ICD implantation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 4 more locations
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
Time frame: 6 months post-ICD implantation
Any inappropriate ICD therapy shock
Efficacy outcome
Time frame: 6 months post-ICD implantation
All-cause mortality
Efficacy outcome
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline and 6 months post-ICD implantation