Avoid Transvenous Leads in Appropriate Subjects
- Conditions
- Ventricular Arrhythmia
- Registration Number
- NCT02881255
- Lead Sponsor
- Population Health Research Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 544
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)
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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;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.
- Secondary Outcome Measures
Name Time Method All-cause mortality 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 ICDTotal 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.Occurrence of failed appropriate shock or arrhythmic death 6 months post-ICD implantation Efficacy outcome
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.
Any inappropriate ICD therapy shock 6 months post-ICD implantation Efficacy outcome
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.
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
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).
Trial Locations
- Locations (14)
University of Calgary
🇨🇦Calgary, Alberta, Canada
Mazankowski Alberta Heart Institute
🇨🇦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
Scroll for more (4 remaining)University of Calgary🇨🇦Calgary, Alberta, Canada