MODE SELECTION TRIAL IN SINUS NODE DYSFUNCTION (MOST)

窦房结功能障碍（大多数）的模式选择试验

• 批准号: 2714039
• 负责人: GERVASIO A LAMAS
• 金额: $ 102.73万
• 依托单位: MOUNT SINAI MEDICAL CENTER (MIAMI BEACH)
• 依托单位国家: 美国
• 财政年份: 1995
• 资助国家: 美国
• 起止时间: 1995-06-01 至 2000-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2714039
• 关键词: clinical biomedical equipment; clinical trials; electrocardiographic monitor; electronic pacemaker; functional ability; health care cost /financing; heart disorder; human mortality; human subject; implant; longitudinal human study; patient care management; patient care planning; quality of life

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.

年，美国大约有13万个心脏起搏器被植入。 1993年，耗资超过10亿美元。 起搏器接受者可能有 植入单腔心室或双腔起搏器。 双 腔室起搏器更昂贵，寿命更短，但 单腔起搏器的心脏起搏器。 这五年的目的 模式选择试验（MOST）是为了确定双腔率是否 病窦综合征患者的调制起搏（DDDR）： 提高无事件生存率; 导致上级生活质量和功能状态; 比频率调制单腔（VVIR）起搏更具成本效益。 MOST的主要终点是一个复合终点，包括所有 导致死亡或中风。 该研究设计有90%的把握度， 检测到组间差异为25%（p=0.05，双尾）。 二次 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，以及非致命性的联合临床终点 中风、心力衰竭住院或死亡。 合格，同意 病窦综合征患者将接受DDDR起搏器植入术 随机无创程控DDDR起搏器植入 并且被随机且非侵入性地编程为DDDR或VVIR。 入组将在3年内进行，随访将从1.5 4.5年。 临床和心电图数据将 通过半年一次的访视进行评估，生活质量将在 通过每年的电话访谈收集1400名患者子集。 保健 支出也将进行评估。 因此，本研究将评估患者获益（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。