Avoid Transvenous Leads in Appropriate Subjects

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.

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)