Avoid Transvenous Leads in Appropriate Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Avoid Transvenous Leads in Appropriate Subjects

Conditions
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Ventricular Arrhythmia

Intervention / Treatment
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* Device: Implantable Cardioverter Defibrillator


Participation Criteria
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Eligibility Criteria
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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: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implantable cardioverter defibrillator, subcutaneous ICD, transvenous ICD, inherited arrhythmia syndrome