title: Rationale and design of the SPICE study-septal positioning of ventricular ICD electrodes.
abstract: OBJECTIVE
  Detrimental effects of right ventricular apical pacing have prompted the search for alternative pacing sites. Data from pacemaker studies suggest that the mid-septum may be a hemodynamically favorable pacing site within the right ventricle. However, data on the safety of implantable cardioverter defibrillator (ICD) lead placement in this location are limited. The aim of the SPICE study is to ascertain that implantation of a ventricular ICD lead at the mid-septum is not inferior to the traditional apical site in terms of feasibility and safety.
  
  
  METHODS
  In total, 286 patients with the indication for ICD implantation will be included in the study and stratified in a 1:1 ratio to have the lead placed in the right ventricular apex or the mid-septum. Primary outcome measure of this randomized, prospective study is the event-free survival of lead-related complications at 3 months. The combined end point includes the feasibility to reach the randomized pacing site in combination with the achievement of adequate pacing, sensing, and defibrillation thresholds. Data analysis and sample size calculation are based on a non-inferiority design.
  
  
  CONCLUSIONS
  This trial will primarily assess the feasibility, safety, and efficacy of right ventricular ICD lead positioning in the mid-septum compared to the traditional apical position. Documentation of non-inferiority of the novel lead position in terms of applicability and safety will be the prerequisite for potential further trials that may evaluate long-term clinical effects associated with mid-septal lead positions.
authors.affiliation: Deutsches Herzzentrum und 1. Medizinische Klinik rechts der Isar, Faculty of Medicine, Technische Universität München, Munich, Germany. kolb@dhm.mhn.de
authors.forename: Christof
authors.initials: C
authors.lastname: Kolb
authors.forename: Stylianos
authors.initials: S
authors.lastname: Tzeis
authors.forename: George
authors.initials: G
authors.lastname: Andrikopoulos
authors.forename: Stefan
authors.initials: S
authors.lastname: Asbach
authors.forename: Bernd
authors.initials: B
authors.lastname: Lemke
authors.forename: Claudius
authors.initials: C
authors.lastname: Hansen
authors.forename: Isabel
authors.initials: I
authors.lastname: Deisenhofer
authors.forename: Bernhard
authors.initials: B
authors.lastname: Zrenner
authors.forename: Frank
authors.initials: F
authors.lastname: Birkenhauer
authors.forename: Panos E
authors.initials: PE
authors.lastname: Vardas
mesh_terms: D018592:Cross-Over Studies; D016757:Death, Sudden, Cardiac / Q000517:prevention & control*; D017147:Defibrillators, Implantable; D004562:Electrocardiography; D005260:Female; D006346:Heart Septum / Q000503:physiopathology*; D006352:Heart Ventricles / Q000503:physiopathology*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D017755:Prosthesis Fitting / Q000379:methods*; D016037:Single-Blind Method; D016896:Treatment Outcome