Clinical trial NCT02881255: Avoid Transvenous Leads in Appropriate Subjects
Official title: Avoid Transvenous Leads in Appropriate Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Arrhythmia
Keywords: implantable cardioverter defibrillator
subcutaneous ICD
transvenous ICD
inherited arrhythmia syndrome
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2016-08-26
Enrollment: 544
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Composite of lead-related perioperative complications
timeFrame: 6 months post-ICD implantation
measure: Additional safety composite
timeFrame: 6 months post-ICD implantation
Secondary outcomes:
measure: Late device-related complications
timeFrame: Greater than 6 months post-ICD implantation
measure: Total device-related complications
timeFrame: Greater than 6 months post-ICD implantation
measure: Occurrence of failed appropriate shock or arrhythmic death
timeFrame: 6 months post-ICD implantation
measure: Hospital, emergency department or clinic visits for ICD therapy, device-related complications, arrhythmia or heart failure
timeFrame: 6 months post-ICD implantation
measure: Any inappropriate ICD therapy shock
timeFrame: 6 months post-ICD implantation
measure: All-cause mortality
timeFrame: 6 months post-ICD implantation
measure: Provincial healthcare payer health economics analysis
timeFrame: 6 months post-ICD implantation
measure: Patient Acceptance of ICD as measured by Florida Patient Acceptance Survey (FPAS)
timeFrame: 1 month and 6 month post-ICD implantation
measure: Patient Health Survey as measured by Short Form Health Survey (SF36)
timeFrame: Baseline and 6 months post-ICD implantation
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Mazankowski Alberta Heart Institute
state: Alberta
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Cardiac Arrhythmia Trials Inc.
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
city: Laval
country: Canada
facility: IUCPQ-Universite Laval
state: Quebec
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: Sherbrooke
country: Canada
facility: Centre Hospitalier Universitaire de Sherbrooke (CHUS)
state: Quebec
Study officials:
affiliation: Population Health Research Institute
name: Jeff Healey, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Université de Montréal
name: Blandine Mondesert, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mondesert B, Bashir J, Philippon F, Dubuc M, Amit G, Exner D, Joza J, Birnie DH, Lane C, Tsang B, Korley V, Spears D, Ling A, Djuric A, Crystal E, Hruczkowski T, Roux JF, Carroll S, Essebag V, Krahn AD, Healey JS. Rationale and design of the randomized prospective ATLAS study: Avoid Transvenous Leads in Appropriate Subjects. Am Heart J. 2019 Jan;207:1-9. doi: 10.1016/j.ahj.2018.09.008. Epub 2018 Oct 9.
citation: Healey JS, Krahn AD, Bashir J, Amit G, Philippon F, McIntyre WF, Tsang B, Joza J, Exner DV, Birnie DH, Sadek M, Leong DP, Sikkel M, Korley V, Sapp JL, Roux JF, Lee SF, Wong G, Djuric A, Spears D, Carroll S, Crystal E, Hruczkowski T, Connolly SJ, Mondesert B; ATLAS Investigators. Perioperative Safety and Early Patient and Device Outcomes Among Subcutaneous Versus Transvenous Implantable Cardioverter Defibrillator Implantations : A Randomized, Multicenter Trial. Ann Intern Med. 2022 Dec;175(12):1658-1665. doi: 10.7326/M22-1566. Epub 2022 Nov 8.