MODE SELECTION TRIAL IN SINUS NODE DYSFUNCTION (MOST)

年，大约有13万人在美国植入了起搏器 1993年，花费远远超过10亿美元。起搏器接受者可能有 植入单腔或双腔起搏器。双人 房间起搏器更昂贵，寿命更短，但更多 生理上，比单腔起搏器。这五年的目的 模式选择试验(MOST)是为了确定双腔率 病态窦房结综合征患者的调制起搏(DDDR)： 提高无事件存活率； 导致卓越的生活质量和功能状态； 比调频单腔起搏(VVIR)更具成本效益。 MOST的主端点是由所有 导致死亡或中风。这项研究的设计具有90%的权力 检测两组之间25%的差异(p=0.05，2个尾随)。次要的 终点包括健康状况和成本效益、总死亡率、 心血管死亡率、房颤的发展、发展 起搏器综合征和非致命性的联合临床终点 中风、心力衰竭、住院或死亡。符合条件，同意 病态窦房结综合征患者将植入DDDR起搏器 并被随机和非侵入性编程植入DDDR起搏器 并被随机且非侵入性地编程为DDDR或VVIR。 注册将在3年内进行，后续将从1.5 几年到四年半。临床和心电数据将是 通过半年一次的访问进行评估，生活质量将在 每年通过电话采访1400名患者。医疗保健 还将评估支出。 因此，本研究将评估患者的益处(临床终点和 健康状况)和起搏模式的社会效益(成本效益) 窦房结功能障碍的选择。

Approximately 130,000 pacemakers were implanted in the United States in 1993, at a cost of well over $1 billion. Pacemaker recipients may have single chamber ventricular or dual chamber pacemakers implanted. Dual chamber pacemakers are more expensive and less long-lived, but more physiologic, than single chamber pacemakers. The purpose of this 5 year mode Selection Trial (MOST) is to determine whether dual chamber rate modulated pacing (DDDR) in patients with sick sinus syndrome: improves event-free survival; leads to superior quality of life and functional status; is more cost-effective than rate modulated single chamber (VVIR) pacing. The primary endpoint of MOST is a composite endpoint consisting of all cause mortality or stroke. The study is designed with a 90% power to detect a 25% difference between groups (p=0.05, 2 tailed). Secondary endpoints include health status and cost-effectiveness, total mortality, cardiovascular mortality, development of atrial fibrillation, development of pacemaker syndrome, and a combined clinical endpoint of non-fatal stroke, heart failure hospitalization, or death. Eligible, consenting patients with sick sinus syndrome will undergo DDDR pacemaker implantation and be randomly and noninvasively programmed to DDDR pacemaker implantation and be randomly and noninvasively programmed to DDDR or to VVIR. Enrollment will take place over 3 years, and follow-up will vary from 1.5 years to 4.5 years. Clinical and electrocardiographic data will be assessed by semi-annual visits, and quality of life will be assessed in a 1400 patient subset by yearly telephone interviews. Health care expenditures also will be assessed. Thus, this study will assess the patient benefits (clinical endpoints and health status), and societal benefits (cost effectiveness) of pacing mode selection in sinus node dysfunction.