心衰心脏再同步CR治疗.ppt

Resynchronization ON = VDD (Biventricular Pacing) Resynchronization OFF = VDI with a lower rate of 30 bpm The design of the study is focused on limiting those factors that could confound the efficacy data. The specific modes defined for use during the study were selected by investigators as being the most appropriate to isolate the effects of biventricular pacing from other confounding effects such as that of rate support. Rate Support: Every attempt will be made to insure that patients remain programmed to the mode to which they were randomized. In the event that a patient develops an indication for rate support and other medical management options have been exhausted, the device may be programmed to an appropriate mode insuring appropriate rate control. Blinding: This study will be double blinded to reduce the impact of placebo effect. Implanting physicians and staff responsible for programming the device will unavoidably know the mode to which the device is programmed. However, neither the patient nor the heart failure physician nor staff supervising the QoL assessment and 6 minute hall walk will have knowledge of the pacing mode assigned. Bias will be reduced by having CORE labs evaluate echocardiographic parameters, plasma neurohormone levels and metabolic exercise results. * Key Points: NYHA functional class, Quality of Life using the validated Minnesota Living with Heart Failure Questionnaire, and the distance walked in 6 minutes are standard measures of clinical outcome in clinical trials of patients with moderate to severe heart failure symptoms. Other important secondary efficacy endpoints—Peak VO2, Exercise Duration during cardiopulmonary exercise, Left Ventricular Ejection Fraction (LVEF), Left Ventricular End Diastolic Dimension (LVEDD), Mitral Regurgitation (MR) were specified to provide insight into the mechanisms. These endpoints were assessed by core laboratories to reduce bias. The Clinical Composite Response is a relatively new method