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

February 1, 2019 updated by: Abbott Medical Devices

Septal Positioning of Ventricular ICD Leads

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

299

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Aalen, Germany, 73430
        • Ost-Alb Klinikum
      • Bad Friedrichshall, Germany, 74177
        • SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
      • Bad Segeberg, Germany, 23795
        • Segeberger Kliniken Gmbh
      • Brandenburg, Germany, 14770
        • Städtisches Klinikum Brandenburg
      • Dachau, Germany, 85221
        • Medizinisches Versorgungszentrum
      • Düren, Germany, 52351
        • Krankenhaus Düren gGmbH Akademisches Lehrkrankenhaus der RWTH-Aachen
      • Esslingen, Germany, 73730
        • Klinikum Esslingen
      • Freiburg, Germany, 79106
        • Universitätsklinik Freiburg
      • Göttingen, Germany, 37073
        • Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
      • Hamburg, Germany, 20099
        • Asklepios Klinik St. Georg
      • Hennigsdorf, Germany, 16761
        • Oberhavel Kliniken GmbH Klinik Hennigsdorf
      • Landshut, Germany, 84036
        • Krankenhaus Landshut-Achdorf
      • Leipzig, Germany, 04103
        • Universitatsklinikum Leipzig AoR
      • Ludwigsburg, Germany, 71640
        • Kliniken Ludwigsburg-Bietigheim
      • Luedenscheid, Germany, 58515
        • Märkische Kliniken GmbH Klinikum Lüdenscheid
      • Mannheim, Germany, 68167
        • Klinikum Mannheim gGmbH Fakultät für Klinische Medizin Mannheim der Universität Heidelberg
      • Munich, Germany, 80636
        • Deutsches Herzzentrum Muenchen
      • Mönchengladbach, Germany, 41063
        • Maria-Hilf Franziskus-Krankenhaus
      • Osnabrück, Germany, 49074
        • Niels-Stensen-Kliniken Marienhospital Osnabrück
      • Peine, Germany, 31228
        • Klinkum Peine gGmbH
  • Greece
      • Athens, Greece, 11526
        • Henry Dunant hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event free survival of RV-ICD-lead related complications
Time Frame: 3 months after implantation
3 months after implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Christoph Kolb, MD, Deutsches Herzzentrum München des Freistaates Bayern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

September 2, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Actual)

February 4, 2019

Last Update Submitted That Met QC Criteria

February 1, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T83

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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