Status:
COMPLETED
Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads
Lead Sponsor:
Abbott Medical Devices
Conditions:
Ventricular Tachycardia
Ventricular Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- Age \>=18 years
- Signed written informed consent
- Approved indication for implantation of ICD / CRT-D device
Exclusion
- 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.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
299 Patients enrolled
Trial Details
Trial ID
NCT00745745
Start Date
August 1 2008
End Date
January 1 2013
Last Update
February 4 2019
Active Locations (21)
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1
Ost-Alb Klinikum
Aalen, Germany, 73430
2
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
Bad Friedrichshall, Germany, 74177
3
Segeberger Kliniken GmbH
Bad Segeberg, Germany, 23795
4
Städtisches Klinikum Brandenburg
Brandenburg, Germany, 14770