Clinical trial NCT00745745: Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads
Official title: Septal Positioning of Ventricular ICD Leads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventricular Tachycardia
Ventricular Fibrillation
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 299
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Event free survival of RV-ICD-lead related complications
timeFrame: 3 months after implantation
Secondary outcomes:
Other outcomes:
Locations:
city: Aalen
country: Germany
facility: Ost-Alb Klinikum
city: Bad Friedrichshall
country: Germany
facility: SLK-Kliniken Heilbronn GmbH Klinikum am Plattenwald
city: Bad Segeberg
country: Germany
facility: Segeberger Kliniken GmbH
city: Brandenburg
country: Germany
facility: Städtisches Klinikum Brandenburg
city: Dachau
country: Germany
facility: Medizinisches Versorgungszentrum
city: Düren
country: Germany
facility: Krankenhaus Düren gGmbH Akademisches Lehrkrankenhaus der RWTH-Aachen
city: Esslingen
country: Germany
facility: Klinikum Esslingen
city: Freiburg
country: Germany
facility: Universitätsklinik Freiburg
city: Göttingen
country: Germany
facility: Herzkatheterlabor der Kardiologischen Praxis am Krankenhaus Neu-Bethlehem gGmbH
city: Hamburg
country: Germany
facility: Asklepios Klinik St. Georg
city: Hennigsdorf
country: Germany
facility: Oberhavel Kliniken GmbH Klinik Hennigsdorf
city: Landshut
country: Germany
facility: Krankenhaus Landshut-Achdorf
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig AÖR
city: Ludwigsburg
country: Germany
facility: Kliniken Ludwigsburg-Bietigheim
city: Luedenscheid
country: Germany
facility: Märkische Kliniken GmbH Klinikum Lüdenscheid
city: Mannheim
country: Germany
facility: Klinikum Mannheim gGmbH Fakultät für Klinische Medizin Mannheim der Universität Heidelberg
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
city: Mönchengladbach
country: Germany
facility: Maria-Hilf Franziskus-Krankenhaus
city: Osnabrück
country: Germany
facility: Niels-Stensen-Kliniken Marienhospital Osnabrück
city: Peine
country: Germany
facility: Klinkum Peine gGmbH
city: Athens
country: Greece
facility: Henry Dunant Hospital
Study officials:
affiliation: Deutsches Herzzentrum München des Freistaates Bayern
name: Christoph Kolb, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.