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: 6017260
• 负责人: GERVASIO A LAMAS
• 金额: $ 209.04万
• 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 2004-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6017260
• 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; medical implant science; 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.

在美国，大约有13万个起搏器被植入