Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Brief summary
This clinical trial is a multi center, prospective, randomized, parallel study designed to compare septal to apical ICD lead placement.
Detailed 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.
Interventions
DEVICEDevice Implantation
ICD lead implantation
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival of RV-ICD-lead related complications | 3 months after implantation |
Countries
Germany, Greece
Outcome results
None listed