Pacing Therapies in Congestive Heart Failure II study

Ventricular resynchronization therapy (VRT) by left or biventricular stimul ation is gaining increasing acceptance as a new therapy in addition to drug s in patients with advanced heart failure and intraventricular conduction d isturbances. Several studies have demonstrated acute hemodynamic benefit of VRT in these patients, although there are only limited long-term data in s mall patient cohorts. Many open questions remain; whether to pace both vent ricles or the left ventricle alone, the optimal left ventricular pacing sit e, the criteria used to identify the optimal candidate for VRT (e.g., QRS w idth), and the importance of an integrated defibrillator function in a VRT device. The Pacing Therapy in Congestive Heart Failure (PATH-CHF) II study is a prospective, randomized, cross-over study currently investigating the potential benefit of VRT in a population wit advanced heart failure, with o r without an accepted indication for an implantable defibrillator. It focus es on the effects of optimized univentricular pacing in these patients, and both acute hemodynamic and chronic functional effects are assessed. Acute hemodynamic testing mainly investigates the impact of different left ventri cular pacing sites, alone or combined with right ventricular sites, on hemo dynamic performance. Primary endpoint of the study is an improvement in fun ctional capacity as assessed by cardiopulmonary exercise testing and 6-minu te walk distance; secondary endpoints include improvement in quality of lif e (assessed by Minnesota quality of life score, New York Heart Association (NYHA) functional class, and hospitalization frequency), and improvements i n prognostic and hemodynamic parameters. The trial aims to enroll 64 patien ts with full datum sets (separately in 2 groups with a QRS of less than or equal to 150 or >150 msec, respectively) in 9 European centers. The enrollm ent began September 1998, and is expected to conclude in summer 2000 to rea ch the number of necessary datum sets. (C) 2000 by Excerpta Medica, Inc.