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

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