Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads (SPICE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
St. Jude Medical
ClinicalTrials.gov Identifier:
NCT00745745
First received: September 2, 2008
Last updated: July 26, 2013
Last verified: July 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Septal Positioning of Ventricular ICD Leads

Resource links provided by NLM:


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 ]

Enrollment: 299
Study Start Date: August 2008
Study Completion Date: January 2013
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Apical ICD lead placement
Device: Device Implantation
ICD lead implantation
Other Names:
  • CE marked ICD/CRT-D from St. Jude Medical and compatible CE marked ICD- and
  • pacemaker- and active fixation ICD-leads
Experimental: 2
Mid-Septal ICD lead placement
Device: Device Implantation
ICD lead implantation
Other Names:
  • CE marked ICD/CRT-D from St. Jude Medical and compatible CE marked ICD- and
  • pacemaker- and active fixation ICD-leads

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Germany
Ost-Alb Klinikum
Aalen, Germany, 73430
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
Bad Friedrichshall, Germany, 74177
Segeberger Kliniken GmbH
Bad Segeberg, Germany, 23795
Städtisches Klinikum Brandenburg
Brandenburg, Germany, 14770
Medizinisches Versorgungszentrum
Dachau, Germany, 85221
Krankenhaus Düren gGmbH Akademisches Lehrkrankenhaus der RWTH-Aachen
Düren, Germany, 52351
Klinikum Esslingen
Esslingen, Germany, 73730
Universitätsklinik Freiburg
Freiburg, Germany, 79106
Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
Göttingen, Germany, 37073
Asklepios Klinik St. Georg
Hamburg, Germany, 20099
Oberhavel Kliniken GmbH Klinik Hennigsdorf
Hennigsdorf, Germany, 16761
Krankenhaus Landshut-Achdorf
Landshut, Germany, 84036
Universitätsklinikum Leipzig AÖR
Leipzig, Germany, 04103
Kliniken Ludwigsburg-Bietigheim
Ludwigsburg, Germany, 71640
Märkische Kliniken GmbH Klinikum Lüdenscheid
Luedenscheid, Germany, 58515
Klinikum Mannheim gGmbH Fakultät für Klinische Medizin Mannheim der Universität Heidelberg
Mannheim, Germany, 68167
Deutsches Herzzentrum Muenchen
Munich, Germany, 80636
Maria-Hilf Franziskus-Krankenhaus
Mönchengladbach, Germany, 41063
Niels-Stensen-Kliniken Marienhospital Osnabrück
Osnabrück, Germany, 49074
Klinkum Peine gGmbH
Peine, Germany, 31228
Greece
Henry Dunant Hospital
Athens, Greece, 11526
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
ClinicalTrials.gov Identifier: NCT00745745     History of Changes
Other Study ID Numbers: T83
Study First Received: September 2, 2008
Last Updated: July 26, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Tachycardia
Ventricular Fibrillation
Tachycardia, Ventricular
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 22, 2014