CRT
Biventricular stimulation to prevent cardiac desynchronization: rationale, design, and endpoints of the ‘Biventricular Pacing for Atrioventricular Block to Prevent Cardiac Desynchronization (BioPace)’ study
1 Department of Cardiology and Angiology, Clinic of Internal Medicine and Cardiology, University Hospital Philipps-University Marburg, Baldingerstr. 1, D-35033 Marburg, Germany; 2 Centre Hospitalier Régional Universitaire de la Cavale Blanche, Brest, France; 3 Institute of Medical Biometry and Epidemiology (IMBE), Philipps-University Marburg, Germany; 4 Coordinating Centre for Clinical Trials (KKS), Philipps-University Marburg, Germany; 5 SJM International, Inc., Brussels, Belgium
Despite the deleterious effects of cardiac dyssynchrony and the positive effects of cardiac resynchronization therapy, patients with high-degree atrioventricular block continue to receive desynchronizing right ventricular (RV) pacing systems. Although it is unclear whether the negative effects of RV pacing and left bundle branch block (LBBB) are comparable, and whether they depend on the presence and the degree of structural heart disease, one may hypothesize that RV pacing may have similar effects to LBBB. In the BioPace trial, the long-term effects of RV pacing vs. biventricular pacing will be prospectively compared in 1200 pacemaker patients with high likelihood of mostly paced ventricular events, regardless of whether in sinus rhythm or in atrial fibrillation (AF). After echocardiographic examination of left ventricular (LV) function, patients will be randomly assigned to the implantation of an RV vs. a biventricular pacing system and followed for up to 5 years. Primary study endpoints are survival, quality of life (QoL), and the distance covered in a 6-min hall walk (6-MHW) at 24 months after implantation. Secondary endpoints are QoL and the 6-MHW result at 12 months after implantation, hospitalization rate, LV dimensions, LV ejection fraction, and the development of chronic AF and other adverse events.
Key Words: Cardiac pacing, Biventricular stimulation, Prevention of cardiac desynchronization, Atrioventricular block, Cardiac resynchronization therapy, Left ventricular dysfunction
* Corresponding author. Tel: +49 6421 28 66462; fax: +49 6421 28 68954. E-mail address: funck{at}mailer.uni-marburg.de