Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02881255
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02881255
Recruitment Status : Recruiting
First Posted : August 26, 2016
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ventricular Arrhythmia Device: Implantable Cardioverter Defibrillator Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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 : February 22, 2017
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

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.




Primary Outcome Measures :
  1. 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.


  2. 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;



Secondary Outcome Measures :
  1. Late device-related complications [ Time Frame: 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

  2. Total device-related complications [ Time Frame: 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.


  3. Occurrence of failed appropriate shock or arrhythmic death [ Time Frame: 6 months post-ICD implantation ]
    Efficacy outcome

  4. Hospital, emergency department or clinic visits for ICD therapy, device-related complications, arrhythmia or heart failure [ Time Frame: 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

  5. Any inappropriate ICD therapy shock [ Time Frame: 6 months post-ICD implantation ]
    Efficacy outcome

  6. All-cause mortality [ Time Frame: 6 months post-ICD implantation ]
    Efficacy outcome

  7. Provincial healthcare payer health economics analysis [ Time Frame: 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.

  8. Patient Acceptance of ICD as measured by Florida Patient Acceptance Survey (FPAS) [ Time Frame: 1 month and 6 month post-ICD implantation ]
    Patient acceptance of ICD will be measured using the Florida Patient Acceptance Survey (FPAS).

  9. Patient Health Survey as measured by Short Form Health Survey (SF36) [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02881255


Contacts
Layout table for location contacts
Contact: Angie Djuric 905-527-4322 ext 40545 atlas@phri.ca

Locations
Layout table for location information
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada
Contact: Derek Exner, MD         
Mazankowski Alberta Heart Institute Recruiting
Edmonton, Alberta, Canada
Contact: Tomasz Hruczkowski, MD         
Canada, British Columbia
St. Paul's Hospital Recruiting
Vancouver, British Columbia, Canada
Contact: Andrew Krahn, MD         
Contact: Jamil Bashir, MD         
Victoria Cardiac Arrhythmia Trials Inc. Recruiting
Victoria, British Columbia, Canada
Contact: Chris Lane, MD         
Canada, Ontario
Hamilton General Hospital Recruiting
Hamilton, Ontario, Canada
Contact: Guy Amit, MD         
Southlake Regional Health Centre Recruiting
Newmarket, Ontario, Canada
Contact: Bernice Tsang, MD         
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada
Contact: David Birnie, MD         
St. Michael's Hospital Recruiting
Toronto, Ontario, Canada
Contact: Victoria Korley, MD         
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada
Contact: Eugene Crystal, MD         
Toronto General Hospital, University Health Network Recruiting
Toronto, Ontario, Canada
Contact: Danna Spears, MD         
Canada, Quebec
IUCPQ-Universite Laval Recruiting
Laval, Quebec, Canada
Contact: Francois Philippon, MD         
Montreal Heart Institute Recruiting
Montreal, Quebec, Canada
Contact: Blandine Mondesert, MD         
McGill University Health Centre Recruiting
Montréal, Quebec, Canada
Contact: Jacqueline Joza, MD         
Centre Hospitalier Universitaire de Sherbrooke (CHUS) Recruiting
Sherbrooke, Quebec, Canada
Contact: Jean-Francois Roux, MD         
Sponsors and Collaborators
Population Health Research Institute
Boston Scientific Corporation
Investigators
Layout table for investigator information
Principal Investigator: Jeff Healey, MD Population Health Research Institute
Principal Investigator: Blandine Mondesert, MD Université de Montréal

Publications:
Layout table for additonal information
Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT02881255     History of Changes
Other Study ID Numbers: ATLAS S-ICD
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Population Health Research Institute:
implantable cardioverter defibrillator
subcutaneous ICD
transvenous ICD
inherited arrhythmia syndrome