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NCT00745745 Clinical Trial

Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads

Ventricular Tachycardia Clinical Trial

— SPICE  

Official title:
Septal Positioning of Ventricular ICD Leads

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00745745
Other study ID # T83
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 2008
Est. completion date January 2013

Study information
Verified date February 2019
Source Abbott Medical Devices
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 299
Est. completion date January 2013
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Device Implantation
ICD lead implantation

Locations
Country Name City State
Germany Ost-Alb Klinikum Aalen
Germany SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald Bad Friedrichshall
Germany Segeberger Kliniken GmbH Bad Segeberg
Germany Städtisches Klinikum Brandenburg Brandenburg
Germany Medizinisches Versorgungszentrum Dachau
Germany Krankenhaus Düren gGmbH Akademisches Lehrkrankenhaus der RWTH-Aachen Düren
Germany Klinikum Esslingen Esslingen
Germany Universitätsklinik Freiburg Freiburg
Germany Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH Göttingen
Germany Asklepios Klinik St. Georg Hamburg
Germany Oberhavel Kliniken GmbH Klinik Hennigsdorf Hennigsdorf
Germany Krankenhaus Landshut-Achdorf Landshut
Germany Universitätsklinikum Leipzig AÖR Leipzig
Germany Kliniken Ludwigsburg-Bietigheim Ludwigsburg
Germany Märkische Kliniken GmbH Klinikum Lüdenscheid Luedenscheid
Germany Klinikum Mannheim gGmbH Fakultät für Klinische Medizin Mannheim der Universität Heidelberg Mannheim
Germany Maria-Hilf Franziskus-Krankenhaus Mönchengladbach
Germany Deutsches Herzzentrum Muenchen Munich
Germany Niels-Stensen-Kliniken Marienhospital Osnabrück Osnabrück
Germany Klinkum Peine gGmbH Peine
Greece Henry Dunant Hospital Athens

Sponsors (1)
Lead Sponsor Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

Germany,  Greece, 

Outcome
Type Measure Description Time frame Safety issue
Primary Event free survival of RV-ICD-lead related complications 3 months after implantation
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