Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads

Septal Positioning of Ventricular ICD Leads

This clinical trial is a multi center, prospective, randomized, parallel study designed to compare septal to apical ICD lead placement.

The primary objective of this clinical investigation is to demonstrate that septal positioning of the right ventricular defibrillation lead is not inferior to the apical positioning in terms of safety and efficacy in a population of ICD recipients.

Inclusion Criteria:

• Age >=18 years
• Signed written informed consent
• Approved indication for implantation of ICD / CRT-D device

Exclusion Criteria:

• Preexisting transvenous RV pacemaker or ICD leads
• Pacemaker dependency without sufficient intrinsic rhythm (≤ 30min-1)
• Hypertrophic obstructive cardiomyopathy
• Presence of intra-aortic balloon pump
• Inotropic drug (not digitalis) necessary for hemodynamic support
• Inability to perform VF induction testing due to anticipated high risk
• Condition likely to limit cooperation
• Unable to give informed consent
• Pregnancy or planned pregnancy in the next 6 months
• Patients with planned cardiac surgery within the next 3 months following randomization
• Patient is currently participating in a clinical investigation that includes an active treatment arm.
• Acute myocardial infarction within the previous 4 weeks.