Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads - Full Text View

Sponsored by:	St. Jude Medical
Information provided by:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT00745745

Purpose

This clinical trial is a multi center, prospective, randomized, parallel study designed to compare septal to apical ICD lead placement.

Condition	Intervention
Ventricular Tachycardia Ventricular Fibrillation	Device: Device Implantation

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Septal Positioning of Ventricular ICD Leads

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Event free survival of RV-ICD-lead related complications [ Time Frame: 3 months after implantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	286
Study Start Date:	August 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Apical ICD lead placement	Device: Device Implantation ICD lead implantation
2: Experimental Mid-Septal ICD lead placement	Device: Device Implantation ICD lead implantation

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745745

Contacts

Contact: Christof Kolb, MD

+49-89-1218-4070

kolb@dhm.mhn.de

Locations

Germany
Deutsches Herzzentrum Muenchen	Recruiting
Munich, Germany, 80636
Contact: Christoph Kolb, MD +49-89-1218 ext 4070 kolb@dhm.mhn.de
Contact: Isabel Deisenhofer, MD +49-89-1218 ext 2020 deisenhofer@dhm.mhn.de
Principal Investigator: Christoph Kolb, MD
Sub-Investigator: Isabel Deisenhofer
Ost-Alb Klinikum	Recruiting
Aalen, Germany, 73430
Contact: Ulrich Solzbach, MD +49-7361/55-1201
Contact: Matthias Beuter, MD +49-7361-55-1201 matthias.beuter@ostalb-klinikum.de
Principal Investigator: Ulrich Solzbach, MD
Sub-Investigator: Matthias Beuter, MD
Sub-Investigator: Helmut Haas, MD
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald	Not yet recruiting
Bad Friedrichshall, Germany, 74177
Contact: Thomas J Dengler, MD +49-7136-28-1492 joachim.manthey@slk-kliniken.de
Principal Investigator: Thomas J Dengler, MD
Universitätsklinik Freiburg	Recruiting
Freiburg, Germany, 79106
Contact: Christoph Bode, MD +49-761-270-0
Principal Investigator: Christoph Bode, MD
Sub-Investigator: Thomas Faber, MD
Märkische Kliniken GmbH Klinikum Lüdenscheid	Recruiting
Luedenscheid, Germany, 58515
Contact: Bernd Lemke, MD +49-2351-46-3326 bernd.lemke@klinikum-luedenscheid.de
Principal Investigator: Bernd Lemke, MD
Sub-Investigator: Axel Kloppe, MD
Sub-Investigator: Harilaos Bogossian, MD
Klinkum Peine gGmbH	Recruiting
Peine, Germany, 31228
Contact: Petra Wacker, MD +49-5171/93-1600 petra.wacker@klinikum-peine.de
Principal Investigator: Petra Wacker, MD
Sub-Investigator: Teofil Lacatusu, MD
Sub-Investigator: Torsten Wendt, MD
Sub-Investigator: Petermax Müller-Marhenke, MD
Sub-Investigator: Astrid Götze, MD
Sub-Investigator: Thomas Krauskopf, MD
Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH	Recruiting
Göttingen, Germany, 37073
Contact: Claudius Hansen, MD +49-551/494-244 hansen@kardiologie-goe.de
Principal Investigator: Vorname Hansen
Städtisches Klinikum Brandenburg	Recruiting
Brandenburg, Germany, 14770
Contact: Stephan Hiller, MD +49-3381-411-504 hiller@klinikum-brandenburg.de
Principal Investigator: Stephan Hiller, MD
Principal Investigator: Michael Oeff
Maria-Hilf Franziskus-Krankenhaus	Not yet recruiting
Mönchengladbach, Germany, 41063
Contact: Istvan R Szendey, MD +49-2161/892-0 SzendeyI@mariahilf.de
Principal Investigator: Istvan R Szendey, MD
Principal Investigator: vom Dahl, MD
Sub-Investigator: Mike Foresti, MD
Krankenhaus Düren gGmbH Akademisches Lehrkrankenhaus der RWTH-Aachen	Recruiting
Düren, Germany, 52351
Contact: Ingo Zillessen, MD 02421 300 Ingo.zillessen@krankenhaus-dueren.de
Principal Investigator: Ingo Zillessen, MD
Universitätsklinikum Leipzig AÖR	Recruiting
Leipzig, Germany, 04103
Contact: Norbert Klein, MD +49-341/97-0 norbert.klein@medizin.uni-leipzig.de
Principal Investigator: Dietrich Pfeiffer, MD
Sub-Investigator: Norbert Klein, MD
Asklepios Klinik St. Georg	Not yet recruiting
Hamburg, Germany, 20099
Contact: Karl-Heinz Kuck, MD +49-40-181885-2450 / -2305 k.kuck@asklepios.com
Principal Investigator: Karl-Heinz Kuck, MD
Sub-Investigator: Michael Riggert, MD
Klinikum der Ruprecht-Karls-Universität Heidelberg	Not yet recruiting
Heidelberg, Germany, 69120
Contact: Alexander Bauer, MD +49-6221/ 56-8676 Alexander.Bauer@med.uni-heidelberg.de
Principal Investigator: Alexander Bauer, MD
Elisabeth-Krankenhaus Essen	Not yet recruiting
Essen, Germany, 45138
Contact: Bernhard Küpper, MD +49-201-897-0 b.kuepper@elisabeth-essen.de
Sub-Investigator: Bernhard Küpper, MD
Principal Investigator: Georg V Sabin, MD
Klinikum Mannheim gGmbH Fakultät für Klinische Medizin Mannheim der Universität Heidelberg	Not yet recruiting
Mannheim, Germany, 68167
Contact: Martin Borggrefe, MD +49-621-383-2204
Principal Investigator: Martin Borggrefe, MD
Sub-Investigator: Jürgen Kuschyk, MD
Sub-Investigator: Florian Streitner, MD
Sub-Investigator: Nina Schoene, MD
Schüchtermann-Schiller´sche Kliniken GmbH & Co. KG	Not yet recruiting
Bad Rothenfelde, Germany, 49214
Contact: Wolfgang Kranig, MD +49-5424-641-1 wkranig@schuechtermann-klinik.de
Principal Investigator: Wolfgang Kranig, MD
Niels-Stensen-Kliniken Marienhospital Osnabrück	Recruiting
Osnabrück, Germany, 49074
Contact: Heinrich Weglage, MD +49-541-326-4110
Principal Investigator: Heinrich Weglage, MD

Sponsors and Collaborators

St. Jude Medical

Investigators

Principal Investigator:

Christoph Kolb, MD

Deutsches Herzzentrum München des Freistaates Bayern

More Information

No publications provided

Responsible Party:	St. Jude Medical GmbH ( Frank Birkenhauer )
Study ID Numbers:	T83
Study First Received:	September 2, 2008
Last Updated:	March 4, 2009
ClinicalTrials.gov Identifier:	NCT00745745 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Paroxysmal Ventricular Fibrillation
Heart Diseases
Tachycardia

Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Pathologic Processes
Heart Diseases
Tachycardia
Cardiovascular Diseases

Tachycardia, Ventricular
Ventricular Fibrillation
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on May 07, 2009