NCT00821938已完成4 期
CRT in Patients With Narrow QRS, Echodesynchronisation and LV dp/Dt-Response With Pressure Wire
Medtronic Cardiac Rhythm and Heart Failure1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Indexed left ventricular volume
研究概览
简要总结
Goal is to examine the efficy of Cardiac Resynchronization Therapy in heart failure patients with narrow QRS complex and optimized medical treatment but echocardiographic desynchronization detection as well as the positve increase of the intraoperative pressureincreasespeed in reverse remodelling and a secondary improvement of functional parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EF < 35%
- •CHD or dilate cardiomyopathy
- •sinus rhythm
- •NYHA III (or IV but stable recompenstated)
- •QRS < 120 ms 2-3 of the following:
- •LV-fillingtime < 40% of the cyclelength
- •TDI septal-lateral (LV basal) > 60ms
- •2D-Strain-Score > 9 points
排除标准
- •tricuspid or artificial valve
- •AV block II or III or PQ time > 250ms
- •revasculisation or condition after cardiac surgery < 3 months
- •myocardial infarction or bypass OP < 3 months
- •hytertrphic obstructive cardiomyopathy, constrictive pericarditis
- •intravenous catecholamines because of HF
- •manifeste hyperthyreoses
- •kidney failure (creatine >2,5 mg/dl)
- •no written informed consent
- •no compliance
- •participation in another study
- •life expectancy < 1 year
- •patients < 18 years
- •pragnancy or no safe contraception
研究组 & 干预措施
CRT-ICD
Active Comparator
干预措施: LV dp/dt pressure measurement (Procedure)
DDD-ICD
Placebo Comparator
干预措施: LV dp/dt pressure measurement (Procedure)
结局指标
主要结局
Indexed left ventricular volume
时间窗: 12 months
次要结局
- NYHA-class, 6 minute hallwalk, QOL, BNP-level, echo-criteria(12 months)
研究者
研究点 (1)
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