Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads
NCT ID: NCT00745745
Last Updated: 2019-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
299 participants
INTERVENTIONAL
2008-08-31
2013-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Apical ICD lead placement
Device Implantation
ICD lead implantation
2
Mid-Septal ICD lead placement
Device Implantation
ICD lead implantation
Interventions
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Device Implantation
ICD lead implantation
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Signed written informed consent
* Approved indication for implantation of ICD / CRT-D device
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Principal Investigators
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Christoph Kolb, MD
Role: PRINCIPAL_INVESTIGATOR
Deutsches Herzzentrum München des Freistaates Bayern
Locations
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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
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
Oberhavel Kliniken GmbH Klinik Hennigsdorf
Hennigsdorf, , Germany
Krankenhaus Landshut-Achdorf
Landshut, , Germany
Universitätsklinikum Leipzig AÖR
Leipzig, , Germany
Kliniken Ludwigsburg-Bietigheim
Ludwigsburg, , Germany
Märkische Kliniken GmbH Klinikum Lüdenscheid
Lüdenscheid, , Germany
Klinikum Mannheim gGmbH Fakultät für Klinische Medizin Mannheim der Universität Heidelberg
Mannheim, , Germany
Maria-Hilf Franziskus-Krankenhaus
Mönchengladbach, , Germany
Deutsches Herzzentrum Muenchen
Munich, , Germany
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück, , Germany
Klinkum Peine gGmbH
Peine, , Germany
Henry Dunant Hospital
Athens, , Greece
Countries
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References
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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.
Other Identifiers
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T83
Identifier Type: -
Identifier Source: org_study_id
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