title: Is there a right place to pace the right ventricle? Evaluation of apical and septal positions in a pacemaker population: study protocol for a prospective intervention-control trial.
abstract: BACKGROUND
  The main objective of research in pacemaker therapy has been to provide the best physiologic way to pace the heart. Despite the good results provided by right ventricular pacing minimization and by biventricular pacing in specific subsets of heart failure patients, these options present many limitations for standard pacemaker recipients. In these patients, pacing the right ventricle at alternative sites could result in a lower degree of left intraventricular dyssynchrony. Despite the lack of strong evidence and the difficulty in placing and accurately classifying the final lead position, pacing at alternative right ventricular sites seems to have become a standard procedure at many implanting centers.
  
  
  METHODS
  The RIGHT PACE study is a multi-center, prospective, single-blind, double-arm, intervention-control trial comparing right ventricular pacing from the apex and from the septal site in terms of left intraventricular dyssynchrony. A total of 408 patients with indications for cardiac pacing but without indications for ICD and/or CRT will be enrolled. Investigators will be divided on the basis of their prior experience of selective site pacing lead implantation and patients will be treated according to the clinical practice of the centers. After device implantation, they will be followed up for 24 months through evaluation of clinical, echocardiographic and safety/system-performance variables.
  
  
  CONCLUSIONS
  This study might provide important information about the impact of the right ventricular pacing on the left ventricular dyssynchrony, and about acute and chronic responses to selective site pacing, as adopted in current clinical practice. This trial is registered at ClinicalTrials.gov (ID:NCT01647490).
  
  
  BACKGROUND
  Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of apical and alternative position. ClinicalTrials.gov: NCT01647490.
authors.affiliation: Cardiology Department, Ospedale S. Maria della Pietà, Nola, Italy. Electronic address: rightpacestudy@gmail.com.
authors.forename: Carmine
authors.initials: C
authors.lastname: Muto
authors.affiliation: Cardiology Department, A.O.U.P. "Vittorio Emanuele", Ospedale Ferrarotto, Catania, Italy.
authors.forename: Valeria
authors.initials: V
authors.lastname: Calvi
authors.affiliation: Cardiology Department, Ospedale S. Anna - Como, San Fermo della Battaglia, CO, Italy.
authors.forename: Giovanni Luca
authors.initials: GL
authors.lastname: Botto
authors.affiliation: Cardiology Department, Ospedale Poliambulanza, Brescia, Italy.
authors.forename: Domenico
authors.initials: D
authors.lastname: Pecora
authors.affiliation: Cardiology Department, A.O.U.P. "Paolo Giaccone", Università degli Studi di Palermo, Palermo, Italy.
authors.forename: Gianfranco
authors.initials: G
authors.lastname: Ciaramitaro
authors.affiliation: CRM Division, Boston Scientific Italia, Milano, Italy.
authors.forename: Sergio
authors.initials: S
authors.lastname: Valsecchi
authors.affiliation: CRM Division, Boston Scientific Italia, Milano, Italy.
authors.forename: Maurizio
authors.initials: M
authors.lastname: Malacrida
authors.affiliation: Cardiology Department, Ospedale Pugliese-Ciaccio, Catanzaro, Italy.
authors.forename: Giampiero
authors.initials: G
authors.lastname: Maglia
mesh_terms: D004452:Echocardiography; D005260:Female; D006333:Heart Failure / Q000401:mortality / Q000628:therapy*; D006352:Heart Ventricles / Q000033:anatomy & histology*; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial; D011446:Prospective Studies; D011788:Quality of Life; D012107:Research Design; D012720:Severity of Illness Index; D016037:Single-Blind Method
keywords: Dyssynchrony; Pacemaker; Review; Septal; Study design