NCT01014000撤回不适用
OPTimization of Left-Ventricular Lead Implantation by Echocardiography- E-OPT Study
Princess Margaret Hospital, Hong Kong2 个研究点 分布在 1 个国家开始时间: 2015年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Clinical response (Improvement in functional class status by at least one NYHA Class or ≥10% increase in 6-minute hall walk distance) to CRT
研究概览
简要总结
Empirical implantation of the left ventricular lead is the prevailing practice in cardiac resynchronization therapy device implantation. The response rate to the therapy has been uniformly 70% only despite various methods to screen patients before device implantation. This study tested the hypothesis that echocardiography to assess acute resynchronization of the left ventricle during device implantation may improve the response rate to the therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with SR or AF, indicated for CRT procedures (NYHA Class III or ambulatory Class IV despite optimal medical therapy, QRSd≥120ms and LVEF≤35%)
- •Patients with ischaemic or non-ischaemic cardiomyopathy can be recruited
排除标准
- •Patients already implanted with an implantable cardiac device, undergoing device upgrade or generator replacement
- •Patients who aged less than 18 or over
- •Patients who are pregnant.
- •Patients who cannot give informed consent.
- •Patients who are judged to have severe mental impairment and cannot report symptoms of heart failure during follow-up.
- •Patients who have comorbid congenital heart disease.
- •Patients who have severe valvular heart disease, apart from severe mitral regurgitation.
- •Patients who have unstable angina or who are within 1 month of myocardial infarction.
- •Patients who have severe lung disease and accurate clinical assessment for heart failure symptoms cannot be performed.
- •Patients who have poor echocardiographic windows precluding reliable echocardiographic examination during baseline assessment, CRT procedures or follow-up.
结局指标
主要结局
Clinical response (Improvement in functional class status by at least one NYHA Class or ≥10% increase in 6-minute hall walk distance) to CRT
时间窗: 6 months after device implantation
次要结局
- Echocardiographic response of ≥15% reduction in LVESV(6 months after device implantation)
- Echocardiographic response of absolute increase of ≥5% in LVEF(6 months after device implantation)
- Biochemical response with reduction of BNP level≥15%(6 months after device implantation)
研究者
Ngai Yin Chan
Dr
Princess Margaret Hospital, Hong Kong
研究点 (2)
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