DYNAMIC CARDIOMYOPLASTY VS STANDARD THERAPY FOR CONGESTIVE HEART FAILURE

动态心肌成形术与充血性心力衰竭的标准治疗

• 批准号: 5216091
• 负责人: MICHAEL A ACKER
• 金额: --
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/5216091
• 关键词: clinical research; congestive heart failure; functional ability; heart disorder chemotherapy; heart surgery; human subject; human therapy evaluation; quality of life

This is a prospective randomized, unblinded, parallel group, multicentered study designed to determine the safety and satisfactory operation of the dynamic cardiomyoplasty operation and stimulation system, as well as to study its effectiveness in improving the functional status and quality of patients with end-stage congestive heart failure. The system and operation will be considered safe if mortality and morbidity in the treatment group are no worse than in the control group, and the procedure will be considered effective if maximal and submaximal exercise improvement, quality of life, and New York Heart Association functional class are greater than a control group (standard medical treatment) outcomes.

这是一个前瞻性随机、非盲、平行组， 多中心研究旨在确定安全性和满意度 动力性心肌成形术及刺激 系统，以及研究其在改善功能的有效性 终末期充血性心力衰竭患者的状态和质量。 系统和操作将被认为是安全的， 治疗组的发病率并不比对照组差， 并且如果最大和次最大，则该过程将被认为是有效的 运动改善、生活质量和纽约心脏协会 功能类大于对照组（标准医疗 治疗）的结果。