ATLAS S-ICD: Avoid Transvenous Leads in Appropriate Subjects

Sponsor

Population Health Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT02881255

Collaborator

Boston Scientific Corporation (Industry)

544

Enrollment

Locations

Arms

59.6

Actual Duration (Months)

38.9

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ventricular Arrhythmia	Device: Implantable Cardioverter Defibrillator	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

544 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Avoid Transvenous Leads in Appropriate Subjects

Actual Study Start Date :

Feb 22, 2017

Actual Primary Completion Date :

Jan 31, 2022

Actual Study Completion Date :

Feb 10, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

Other: Subcutaneous ICD

Patient will receive a subcutaneous implantable cardioverter defibrillator (Boston Scientific EMBLEM)

Device: Implantable Cardioverter Defibrillator

Patients will be randomized to receive either a subcutaneous or transvenous ICD.

Other: Transvenous ICD

Patient will receive a single-chamber, transvenous implantable cardioverter defibrillator (from any manufacturer) which as the capability for remote monitoring.

Device: Implantable Cardioverter Defibrillator

Patients will be randomized to receive either a subcutaneous or transvenous ICD.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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.
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
All-cause mortality [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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country
1	University of Calgary	Calgary	Alberta	Canada
2	Mazankowski Alberta Heart Institute	Edmonton	Alberta	Canada
3	St. Paul's Hospital	Vancouver	British Columbia	Canada
4	Victoria Cardiac Arrhythmia Trials Inc.	Victoria	British Columbia	Canada
5	Hamilton General Hospital	Hamilton	Ontario	Canada
6	Southlake Regional Health Centre	Newmarket	Ontario	Canada
7	University of Ottawa Heart Institute	Ottawa	Ontario	Canada
8	St. Michael's Hospital	Toronto	Ontario	Canada
9	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada
10	Toronto General Hospital, University Health Network	Toronto	Ontario	Canada
11	IUCPQ-Universite Laval	Laval	Quebec	Canada
12	Montreal Heart Institute	Montreal	Quebec	Canada
13	McGill University Health Centre	Montréal	Quebec	Canada
14	Centre Hospitalier Universitaire de Sherbrooke (CHUS)	Sherbrooke	Quebec	Canada