Avoid Transvenous Leads in Appropriate Subjects
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 544
- Locations
- 14
- Primary Endpoint
- Additional safety composite
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Subcutaneous ICD
Patient will receive a subcutaneous implantable cardioverter defibrillator (Boston Scientific EMBLEM)
Intervention: Implantable Cardioverter Defibrillator (Device)
Transvenous ICD
Patient will receive a single-chamber, transvenous implantable cardioverter defibrillator (from any manufacturer) which as the capability for remote monitoring.
Intervention: Implantable Cardioverter Defibrillator (Device)
Outcomes
Primary Outcomes
Additional safety composite
Time Frame: 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;
Composite of lead-related perioperative complications
Time Frame: 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.
Secondary Outcomes
- Late device-related complications(Greater than 6 months post-ICD implantation)
- All-cause mortality(6 months post-ICD implantation)
- Total device-related complications(Greater than 6 months post-ICD implantation)
- Occurrence of failed appropriate shock or arrhythmic death(6 months post-ICD implantation)
- Patient Health Survey as measured by Short Form Health Survey (SF36)(Baseline and 6 months post-ICD implantation)
- Any inappropriate ICD therapy shock(6 months post-ICD implantation)
- Provincial healthcare payer health economics analysis(6 months post-ICD implantation)
- Hospital, emergency department or clinic visits for ICD therapy, device-related complications, arrhythmia or heart failure(6 months post-ICD implantation)
- Patient Acceptance of ICD as measured by Florida Patient Acceptance Survey (FPAS)(1 month and 6 month post-ICD implantation)