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

• Published in: Contemporary clinical trials 2014-11, Vol.39 (2), p.320-326
• Main Authors: Muto, Carmine, Calvi, Valeria, Botto, Giovanni Luca, Pecora, Domenico, Ciaramitaro, Gianfranco, Valsecchi, Sergio, Malacrida, Maurizio, Maglia, Giampiero
• Format: Article
• Language: English
• Subjects: Cardiovascular; Dyssynchrony; Echocardiography; Female; Heart Failure - mortality; Heart Failure - therapy; Heart Ventricles - anatomy & histology; Hematology, Oncology and Palliative Medicine; Hospitalization - statistics & numerical data; Humans; Male; Pacemaker; Pacemaker, Artificial; Prospective Studies; Quality of Life; Research Design; Review; Septal; Severity of Illness Index; Single-Blind Method; Study design
• ISSN: 1551-7144; 1559-2030
• DOI: 10.1016/j.cct.2014.10.006

Abstract Introduction 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. Material and 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. Discussion 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 ). Trial registration Right Ventricular Lead Placement in a Pacemaker Population: Evaluation of apical and alternative position. ClinicalTrials.gov : NCT01647490.