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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Apical ICD lead placement |
|
| 2 | Experimental | Mid-Septal ICD lead placement |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Device Implantation | Device | ICD lead implantation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Event free survival of RV-ICD-lead related complications | 3 months after implantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Kolb, MD | Deutsches Herzzentrum München des Freistaates Bayern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ost-Alb Klinikum | Aalen | 73430 | Germany | |||
| SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24838056 | Derived | Kolb C, Solzbach U, Biermann J, Semmler V, Kloppe A, Klein N, Lennerz C, Szendey I, Andrikopoulos G, Tzeis S, Asbach S; SPICE-investigators. Safety of mid-septal electrode placement in implantable cardioverter defibrillator recipients--results of the SPICE (Septal Positioning of ventricular ICD Electrodes) study. Int J Cardiol. 2014 Jul 1;174(3):713-20. doi: 10.1016/j.ijcard.2014.04.229. Epub 2014 Apr 26. |
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| Bad Friedrichshall |
| 74177 |
| Germany |
| Segeberger Kliniken GmbH | Bad Segeberg | 23795 | Germany |
| Städtisches Klinikum Brandenburg | Brandenburg | 14770 | Germany |
| Medizinisches Versorgungszentrum | Dachau | 85221 | Germany |
| Krankenhaus Düren gGmbH Akademisches Lehrkrankenhaus der RWTH-Aachen | Düren | 52351 | Germany |
| Klinikum Esslingen | Esslingen am Neckar | 73730 | Germany |
| Universitätsklinik Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH | Göttingen | 37073 | Germany |
| Asklepios Klinik St. Georg | Hamburg | 20099 | Germany |
| Oberhavel Kliniken GmbH Klinik Hennigsdorf | Hennigsdorf | 16761 | Germany |
| Krankenhaus Landshut-Achdorf | Landshut | 84036 | Germany |
| Universitätsklinikum Leipzig AÖR | Leipzig | 04103 | Germany |
| Kliniken Ludwigsburg-Bietigheim | Ludwigsburg | 71640 | Germany |
| Märkische Kliniken GmbH Klinikum Lüdenscheid | Lüdenscheid | 58515 | Germany |
| Klinikum Mannheim gGmbH Fakultät für Klinische Medizin Mannheim der Universität Heidelberg | Mannheim | 68167 | Germany |
| Maria-Hilf Franziskus-Krankenhaus | Mönchengladbach | 41063 | Germany |
| Deutsches Herzzentrum Muenchen | Munich | 80636 | Germany |
| Niels-Stensen-Kliniken Marienhospital Osnabrück | Osnabrück | 49074 | Germany |
| Klinkum Peine gGmbH | Peine | 31228 | Germany |
| Henry Dunant Hospital | Athens | 11526 | Greece |
| ID | Term |
|---|---|
| D017180 | Tachycardia, Ventricular |
| D014693 | Ventricular Fibrillation |
| ID | Term |
|---|---|
| D013610 | Tachycardia |
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000075224 | Cardiac Conduction System Disease |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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