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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
299
ICD lead implantation
Ost-Alb Klinikum
Aalen, Germany
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
Event free survival of RV-ICD-lead related complications
Time frame: 3 months after implantation
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Bad Friedrichshall, Germany
Segeberger Kliniken GmbH
Bad Segeberg, Germany
Städtisches Klinikum Brandenburg
Brandenburg, Germany
Medizinisches Versorgungszentrum
Dachau, Germany
Krankenhaus Düren gGmbH Akademisches Lehrkrankenhaus der RWTH-Aachen
Düren, Germany
Klinikum Esslingen
Esslingen am Neckar, Germany
Universitätsklinik Freiburg
Freiburg im Breisgau, Germany
Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
Göttingen, Germany
Asklepios Klinik St. Georg
Hamburg, Germany
...and 11 more locations