Table 2 Studies planned or in an early phase
Study | Lead implant | Inclusion criteria | Design | Primary endpoint | Secondary endpoint | Expected completion/outcome if known |
|---|---|---|---|---|---|---|
PACMAN | Transvenous | NYHA III EF < 35% QRS > 150 ms (NYHA I + II data recorded in registry) 300 patients | Two patient groups (1) NYHA III + indication for AICD (2) NYHA III with no indication for AICD Biventricular pacing ON or OFF for 6 months | 6 min walk | Quality of life Rehospitalisation | Estimated completion 2002/2003 |
MIRACLE | Transvenous | NYHA III/IV CHF Sinus rhythm QRS duration ≥ 130 ms EF ≤ 35% | Randomised double-blind biventricular pacing or no pacing for 6/12 months, then active pacing for long-term follow-up | 6 min walk distance QOL NYHA | Neurohormones Echo indices VO2 max | Recruitment completed 2000 Early results Spring 2001 |
COMPANION | Transvenous | NYHA III / IV for > 6/12 months QRS > 120 EF < 35% > 1 hospital admission in past year 2200 patients | Three treatment arms: (1) Biventricular + AICD + OT (2) OT (3) Biventricular + OT | All-cause mortality and hospitalisation | Total mortality and morbidity Symptoms and function | Estimated completion Dec 2002 |
RELEVENT | Transvenous | NYHA II-IV EF < 35% QRS > 140 ms LVEDD > 55 mm 400 patients | Two groups (1) 50% of patients; optimal medical therapy only (OT)(2) OT + LV based pacing (BiV or LV) Studied at 1 and 6 months, then every 6/12 months for 2 years | Safety and mortality | QOL Echo indicies Total mortality | Not yet started 2.5 year study |
CARE HF | Transvenous | CHF with EF < 35% QRS ≥ 150 ms NYHA III/IV | Randomised biventricular pacing + optimal therapy Optimal therapy and no implant | All-cause mortality or hospital admissions CHF VO2 max 6 min walk | NYHA status QOL Neurohormones Echocardiographic assessment | Not yet started Estimated completion 2003 |