search
Back to results

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

Primary Purpose

Ventricular Tachycardia, Ventricular Fibrillation

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Device Implantation
Sponsored by
Abbott Medical Devices
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ost-Alb Klinikum
  • SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
  • Segeberger Kliniken GmbH
  • Städtisches Klinikum Brandenburg
  • Medizinisches Versorgungszentrum
  • Krankenhaus Düren gGmbH Akademisches Lehrkrankenhaus der RWTH-Aachen
  • Klinikum Esslingen
  • Universitätsklinik Freiburg
  • Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
  • Asklepios Klinik St. Georg
  • Oberhavel Kliniken GmbH Klinik Hennigsdorf
  • Krankenhaus Landshut-Achdorf
  • Universitätsklinikum Leipzig AÖR
  • Kliniken Ludwigsburg-Bietigheim
  • Märkische Kliniken GmbH Klinikum Lüdenscheid
  • Klinikum Mannheim gGmbH Fakultät für Klinische Medizin Mannheim der Universität Heidelberg
  • Deutsches Herzzentrum Muenchen
  • Maria-Hilf Franziskus-Krankenhaus
  • Niels-Stensen-Kliniken Marienhospital Osnabrück
  • Klinkum Peine gGmbH
  • Henry Dunant Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

Apical ICD lead placement

Mid-Septal ICD lead placement

Outcomes

Primary Outcome Measures

Event free survival of RV-ICD-lead related complications

Secondary Outcome Measures

Full Information

First Posted
September 2, 2008
Last Updated
February 1, 2019
Sponsor
Abbott Medical Devices
search

1. Study Identification

Unique Protocol Identification Number
NCT00745745
Brief Title
Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads
Acronym
SPICE
Official Title
Septal Positioning of Ventricular ICD Leads
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Devices

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia, Ventricular Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
299 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Apical ICD lead placement
Arm Title
2
Arm Type
Experimental
Arm Description
Mid-Septal ICD lead placement
Intervention Type
Device
Intervention Name(s)
Device Implantation
Other Intervention Name(s)
CE marked ICD/CRT-D from St. Jude Medical and compatible CE marked ICD- and, pacemaker- and active fixation ICD-leads
Intervention Description
ICD lead implantation
Primary Outcome Measure Information:
Title
Event free survival of RV-ICD-lead related complications
Time Frame
3 months after implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Kolb, MD
Organizational Affiliation
Deutsches Herzzentrum München des Freistaates Bayern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ost-Alb Klinikum
City
Aalen
ZIP/Postal Code
73430
Country
Germany
Facility Name
SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
City
Bad Friedrichshall
ZIP/Postal Code
74177
Country
Germany
Facility Name
Segeberger Kliniken GmbH
City
Bad Segeberg
ZIP/Postal Code
23795
Country
Germany
Facility Name
Städtisches Klinikum Brandenburg
City
Brandenburg
ZIP/Postal Code
14770
Country
Germany
Facility Name
Medizinisches Versorgungszentrum
City
Dachau
ZIP/Postal Code
85221
Country
Germany
Facility Name
Krankenhaus Düren gGmbH Akademisches Lehrkrankenhaus der RWTH-Aachen
City
Düren
ZIP/Postal Code
52351
Country
Germany
Facility Name
Klinikum Esslingen
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Universitätsklinik Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
City
Göttingen
ZIP/Postal Code
37073
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Oberhavel Kliniken GmbH Klinik Hennigsdorf
City
Hennigsdorf
ZIP/Postal Code
16761
Country
Germany
Facility Name
Krankenhaus Landshut-Achdorf
City
Landshut
ZIP/Postal Code
84036
Country
Germany
Facility Name
Universitätsklinikum Leipzig AÖR
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Kliniken Ludwigsburg-Bietigheim
City
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
Facility Name
Märkische Kliniken GmbH Klinikum Lüdenscheid
City
Luedenscheid
ZIP/Postal Code
58515
Country
Germany
Facility Name
Klinikum Mannheim gGmbH Fakultät für Klinische Medizin Mannheim der Universität Heidelberg
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Deutsches Herzzentrum Muenchen
City
Munich
ZIP/Postal Code
80636
Country
Germany
Facility Name
Maria-Hilf Franziskus-Krankenhaus
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
Niels-Stensen-Kliniken Marienhospital Osnabrück
City
Osnabrück
ZIP/Postal Code
49074
Country
Germany
Facility Name
Klinkum Peine gGmbH
City
Peine
ZIP/Postal Code
31228
Country
Germany
Facility Name
Henry Dunant Hospital
City
Athens
ZIP/Postal Code
11526
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
24838056
Citation
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.
Results Reference
derived

Learn more about this trial

Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads

We'll reach out to this number within 24 hrs