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

Population Health Research Institute (PHRI) logo

Population Health Research Institute (PHRI)

Status

Completed

Conditions

Ventricular Arrhythmia

Treatments

Device: Implantable Cardioverter Defibrillator

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02881255
ATLAS S-ICD

Details and patient eligibility

About

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.

Enrollment

544 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

544 participants in 2 patient groups

Subcutaneous ICD
Other group
Description:
Patient will receive a subcutaneous implantable cardioverter defibrillator (Boston Scientific EMBLEM)
Treatment:
Device: Implantable Cardioverter Defibrillator
Transvenous ICD
Other group
Description:
Patient will receive a single-chamber, transvenous implantable cardioverter defibrillator (from any manufacturer) which as the capability for remote monitoring.
Treatment:
Device: Implantable Cardioverter Defibrillator

Trial contacts and locations

14

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Data sourced from clinicaltrials.gov

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