Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads (SPICE)

Abbott

Status

Completed

Conditions

Ventricular Fibrillation

Ventricular Tachycardia

Treatments

Device: Device Implantation

Study type

Interventional

Funder types

Industry

Identifiers

NCT00745745

T83

Details and patient eligibility

About

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

Full description

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.

Enrollment

299 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.