Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads

Not Applicable

Completed

• Conditions: Ventricular Fibrillation; Ventricular Tachycardia
• Interventions: Device: Device Implantation

• Registration Number: NCT00745745
• Lead Sponsor: Abbott Medical Devices

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-09-02
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Primary Completion: 2011-06
• Study Completion: 2013-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-01
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 299

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Device Implantation	Mid-Septal ICD lead placement
1	Device Implantation	Apical ICD lead placement

Primary Outcome Measures

Name	Time	Method
Event free survival of RV-ICD-lead related complications	3 months after implantation

Trial Locations

Locations (21)

Maria-Hilf Franziskus-Krankenhaus; 🇩🇪 Mönchengladbach, Germany

Henry Dunant Hospital; 🇬🇷 Athens, Greece

Medizinisches Versorgungszentrum; 🇩🇪 Dachau, Germany

Ost-Alb Klinikum; 🇩🇪 Aalen, Germany

SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald; 🇩🇪 Bad Friedrichshall, Germany

Segeberger Kliniken GmbH; 🇩🇪 Bad Segeberg, Germany

Städtisches Klinikum Brandenburg; 🇩🇪 Brandenburg, Germany

Klinikum Esslingen; 🇩🇪 Esslingen, Germany

Asklepios Klinik St. Georg; 🇩🇪 Hamburg, Germany

Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH; 🇩🇪 Göttingen, Germany

Märkische Kliniken GmbH Klinikum Lüdenscheid; 🇩🇪 Luedenscheid, Germany

Oberhavel Kliniken GmbH Klinik Hennigsdorf; 🇩🇪 Hennigsdorf, Germany

Krankenhaus Landshut-Achdorf; 🇩🇪 Landshut, Germany

Krankenhaus Düren gGmbH Akademisches Lehrkrankenhaus der RWTH-Aachen; 🇩🇪 Düren, Germany

Universitätsklinik Freiburg; 🇩🇪 Freiburg, Germany

Kliniken Ludwigsburg-Bietigheim; 🇩🇪 Ludwigsburg, Germany

Universitätsklinikum Leipzig AÖR; 🇩🇪 Leipzig, Germany

Klinikum Mannheim gGmbH Fakultät für Klinische Medizin Mannheim der Universität Heidelberg; 🇩🇪 Mannheim, Germany

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Germany

Niels-Stensen-Kliniken Marienhospital Osnabrück; 🇩🇪 Osnabrück, Germany

Klinkum Peine gGmbH; 🇩🇪 Peine, Germany