NCT00745745

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
299

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2008

Longer than P75 for not_applicable

Geographic Reach
2 countries

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 3, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 4, 2019

Status Verified

February 1, 2019

Enrollment Period

2.8 years

First QC Date

September 2, 2008

Last Update Submit

February 1, 2019

Conditions

Ventricular TachycardiaVentricular Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Event free survival of RV-ICD-lead related complications

    3 months after implantation

Study Arms (2)

1

ACTIVE COMPARATOR

Apical ICD lead placement

Device: Device Implantation

2

EXPERIMENTAL

Mid-Septal ICD lead placement

Device: Device Implantation

Interventions

Device ImplantationDEVICE

ICD lead implantation

Also known as: CE marked ICD/CRT-D from St. Jude Medical and compatible CE marked ICD- and, pacemaker- and active fixation ICD-leads
12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>=18 years
  • Signed written informed consent
  • Approved indication for implantation of ICD / CRT-D device

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Ost-Alb Klinikum

Aalen, 73430, Germany

Location

SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald

Bad Friedrichshall, 74177, Germany

Location

Segeberger Kliniken GmbH

Bad Segeberg, 23795, Germany

Location

Städtisches Klinikum Brandenburg

Brandenburg, 14770, Germany

Location

Medizinisches Versorgungszentrum

Dachau, 85221, Germany

Location

Krankenhaus Düren gGmbH Akademisches Lehrkrankenhaus der RWTH-Aachen

Düren, 52351, Germany

Location

Klinikum Esslingen

Esslingen am Neckar, 73730, Germany

Location

Universitätsklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH

Göttingen, 37073, Germany

Location

Asklepios Klinik St. Georg

Hamburg, 20099, Germany

Location

Oberhavel Kliniken GmbH Klinik Hennigsdorf

Hennigsdorf, 16761, Germany

Location

Krankenhaus Landshut-Achdorf

Landshut, 84036, Germany

Location

Universitätsklinikum Leipzig AÖR

Leipzig, 04103, Germany

Location

Kliniken Ludwigsburg-Bietigheim

Ludwigsburg, 71640, Germany

Location

Märkische Kliniken GmbH Klinikum Lüdenscheid

Lüdenscheid, 58515, Germany

Location

Klinikum Mannheim gGmbH Fakultät für Klinische Medizin Mannheim der Universität Heidelberg

Mannheim, 68167, Germany

Location

Maria-Hilf Franziskus-Krankenhaus

Mönchengladbach, 41063, Germany

Location

Deutsches Herzzentrum Muenchen

Munich, 80636, Germany

Location

Niels-Stensen-Kliniken Marienhospital Osnabrück

Osnabrück, 49074, Germany

Location

Klinkum Peine gGmbH

Peine, 31228, Germany

Location

Henry Dunant Hospital

Athens, 11526, Greece

Location

Related Publications (1)

  • 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.

    PMID: 24838056DERIVED

MeSH Terms

Conditions

Tachycardia, VentricularVentricular Fibrillation

Condition Hierarchy (Ancestors)

TachycardiaArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Christoph Kolb, MD

    Deutsches Herzzentrum München des Freistaates Bayern

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 2, 2008

First Posted

September 3, 2008

Study Start

August 1, 2008

Primary Completion

June 1, 2011

Study Completion

January 1, 2013

Last Updated

February 4, 2019

Record last verified: 2019-02

Locations

GR(1)DE(20)