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Avoid Transvenous Leads in Appropriate Subjects (ATLAS S-ICD)

Primary Purpose

Ventricular Arrhythmia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Implantable Cardioverter Defibrillator
Sponsored by
Population Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ventricular Arrhythmia focused on measuring implantable cardioverter defibrillator, subcutaneous ICD, transvenous ICD, inherited arrhythmia syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • University of Calgary
  • Mazankowski Alberta Heart Institute
  • St. Paul's Hospital
  • Victoria Cardiac Arrhythmia Trials Inc.
  • Hamilton General Hospital
  • Southlake Regional Health Centre
  • University of Ottawa Heart Institute
  • St. Michael's Hospital
  • Sunnybrook Health Sciences Centre
  • Toronto General Hospital, University Health Network
  • IUCPQ-Universite Laval
  • Montreal Heart Institute
  • McGill University Health Centre
  • Centre Hospitalier Universitaire de Sherbrooke (CHUS)

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Subcutaneous ICD

Transvenous ICD

Arm Description

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

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

Outcomes

Primary Outcome Measures

Composite of lead-related perioperative complications
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
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
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
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
Efficacy outcome
Hospital, emergency department or clinic visits for ICD therapy, device-related complications, arrhythmia or heart failure
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
Efficacy outcome
All-cause mortality
Efficacy outcome
Provincial healthcare payer health economics analysis
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)
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)
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.

Full Information

First Posted
August 2, 2016
Last Updated
May 26, 2022
Sponsor
Population Health Research Institute
Collaborators
Boston Scientific Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02881255
Brief Title
Avoid Transvenous Leads in Appropriate Subjects
Acronym
ATLAS S-ICD
Official Title
Avoid Transvenous Leads in Appropriate Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
February 22, 2017 (Actual)
Primary Completion Date
January 31, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Population Health Research Institute
Collaborators
Boston Scientific Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Arrhythmia
Keywords
implantable cardioverter defibrillator, subcutaneous ICD, transvenous ICD, inherited arrhythmia syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
544 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subcutaneous ICD
Arm Type
Other
Arm Description
Patient will receive a subcutaneous implantable cardioverter defibrillator (Boston Scientific EMBLEM)
Arm Title
Transvenous ICD
Arm Type
Other
Arm Description
Patient will receive a single-chamber, transvenous implantable cardioverter defibrillator (from any manufacturer) which as the capability for remote monitoring.
Intervention Type
Device
Intervention Name(s)
Implantable Cardioverter Defibrillator
Intervention Description
Patients will be randomized to receive either a subcutaneous or transvenous ICD.
Primary Outcome Measure Information:
Title
Composite of lead-related perioperative complications
Description
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.
Time Frame
6 months post-ICD implantation
Title
Additional safety composite
Description
This composite includes: Device-related infection requiring surgical revision; Significant wound hematoma (requiring evacuation or interruption of oral anticoagulation); Myocardial infarction; Stroke; Death;
Time Frame
6 months post-ICD implantation
Secondary Outcome Measure Information:
Title
Late device-related complications
Description
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
Time Frame
Greater than 6 months post-ICD implantation
Title
Total device-related complications
Description
This is a composite of: all components of the primary and secondary safety outcomes, and late device-related complications.
Time Frame
Greater than 6 months post-ICD implantation
Title
Occurrence of failed appropriate shock or arrhythmic death
Description
Efficacy outcome
Time Frame
6 months post-ICD implantation
Title
Hospital, emergency department or clinic visits for ICD therapy, device-related complications, arrhythmia or heart failure
Description
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
Time Frame
6 months post-ICD implantation
Title
Any inappropriate ICD therapy shock
Description
Efficacy outcome
Time Frame
6 months post-ICD implantation
Title
All-cause mortality
Description
Efficacy outcome
Time Frame
6 months post-ICD implantation
Title
Provincial healthcare payer health economics analysis
Description
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.
Time Frame
6 months post-ICD implantation
Title
Patient Acceptance of ICD as measured by Florida Patient Acceptance Survey (FPAS)
Description
Patient acceptance of ICD will be measured using the Florida Patient Acceptance Survey (FPAS).
Time Frame
1 month and 6 month post-ICD implantation
Title
Patient Health Survey as measured by Short Form Health Survey (SF36)
Description
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.
Time Frame
Baseline and 6 months post-ICD implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Healey, MD
Organizational Affiliation
Population Health Research Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Blandine Mondesert, MD
Organizational Affiliation
Université de Montréal
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
Country
Canada
Facility Name
Mazankowski Alberta Heart Institute
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Victoria Cardiac Arrhythmia Trials Inc.
City
Victoria
State/Province
British Columbia
Country
Canada
Facility Name
Hamilton General Hospital
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Southlake Regional Health Centre
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Toronto General Hospital, University Health Network
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
IUCPQ-Universite Laval
City
Laval
State/Province
Quebec
Country
Canada
Facility Name
Montreal Heart Institute
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
McGill University Health Centre
City
Montréal
State/Province
Quebec
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Sherbrooke (CHUS)
City
Sherbrooke
State/Province
Quebec
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30399474
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.
Results Reference
background
PubMed Identifier
36343346
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.
Results Reference
derived

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Avoid Transvenous Leads in Appropriate Subjects

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