Skip to main content
OpenTrials
Completed

NCT Number: NCT02881255

Avoid Transvenous Leads in Appropriate Subjects

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Ventricular Arrhythmia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Implantable Cardioverter Defibrillator

Device

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Collaborators

  • Boston Scientific Corporation

Registry information

Acronym: ATLAS S-ICD

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2016
Registry last updated
May 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.