|  |  |  |  |  | Expected completion/outcome |
---|---|---|---|---|---|---|
Study | Lead implant | Inclusion criteria | Design | Primary endpoint | Secondary endpoint | if known |
VIGOR CHF [22] | Thoracotomy | Severe CHF due to DCM sinus rhythm intraventricular conduction delay | Randomised single-blind active versus no pacing for 6 weeks then VDD for a further 12 weeks | VO2 max | 6 min walk distance Quality of life questionnaire Plasma norepinephrine | Study will be reported shortly |
VENTAK | Â | Â | Â | Â | Echocardiographic assessment | Completion Spring 2001 |
PATH CHF [40] | Thoracotomy | NYHA III/IV CHF Sinus rhythm > 55/min QRS > 120 ms PR > 150 ms; 42 patients | (1) Acute phase: acute haemodynamic study at time of implant to evaluate optimal pacing site and AV delay | Haemodynamics | - | (1) LV pacing superior to biventricular; both superior to RV pacing; optimisation of AV delay important |
 |  |  | (2) Chronic phase: single-blind, cross-over study biventricular pacing versus best unventricular pacing site assessed in acute study | VO2 max 6 min walk distance | Quality of life questionnaire Echocardiographic assessment | (2) Significant improvement in all end points |
InSYNC | Transvenous | NYHA III / IV (48% IHD) EF < 35% LVEDD > 60 mm QRS > 150 ms 103 patients on optimal therapy | Non-randomised trial Patients were implanted with biventricular pacer and assessed at 1, 3, 6 and 12 months | 6 min walk distance QRS duration | NYHA class Quality of life | Completed Improvement in QOL, 6 min walk, reduction in QRS, symptoms irrespective of aetiology |
MUSTIC [35] | Transvenous | NYHA III, EF < 35% QRS ≥ 150 or 180 for AF group Group I: sinus rhythm Group II: AF with AV node ablation | Single-blind, randomised, cross-over 12 weeks of biventricular versus no ventricular stimulation followed by a longitudinal phase in the patients preferred mode | 6 min walk distance VO2 max | Mortality or need for transplant/LVAD QOL Rehospitalisation and/or changes in drug therapy for decompensated CHF | Results in sinus rhythm group → improved 6 min walk distance, VO2 max and QOL AF data to be presented late 2000 |