Ventricular Arrhythmia
Conditions
Keywords
implantable cardioverter defibrillator, subcutaneous ICD, transvenous ICD, inherited arrhythmia syndrome
Brief summary
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.
Interventions
DEVICEImplantable Cardioverter Defibrillator
Patients will be randomized to receive either a subcutaneous or transvenous ICD.
Sponsors
Boston Scientific Corporation
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of lead-related perioperative complications | 6 months post-ICD implantation | 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. |
| Additional safety composite | 6 months post-ICD implantation | This composite includes: Device-related infection requiring surgical revision; Significant wound hematoma (requiring evacuation or interruption of oral anticoagulation); Myocardial infarction; Stroke; Death; |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of failed appropriate shock or arrhythmic death | 6 months post-ICD implantation | Efficacy outcome |
| Hospital, emergency department or clinic visits for ICD therapy, device-related complications, arrhythmia or heart failure | 6 months post-ICD implantation | 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 |
| Any inappropriate ICD therapy shock | 6 months post-ICD implantation | Efficacy outcome |
| Late device-related complications | Greater than 6 months post-ICD implantation | 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 |
| Provincial healthcare payer health economics analysis | 6 months post-ICD implantation | 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. |
| Patient Acceptance of ICD as measured by Florida Patient Acceptance Survey (FPAS) | 1 month and 6 month post-ICD implantation | Patient acceptance of ICD will be measured using the Florida Patient Acceptance Survey (FPAS). |
| Patient Health Survey as measured by Short Form Health Survey (SF36) | Baseline and 6 months post-ICD implantation | 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. |
| All-cause mortality | 6 months post-ICD implantation | Efficacy outcome |
| Total device-related complications | Greater than 6 months post-ICD implantation | This is a composite of: all components of the primary and secondary safety outcomes, and late device-related complications. |
Countries
Canada
Outcome results
None listed