NCT01642927撤回不适用
Pulse Wave Analysis in Advanced Heart Failure Patients Before and After Ventricular Assist Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Observation of pulse wave signatures in LVAD patients
研究概览
简要总结
A comparison of pulse wave characteristics, as measured by peripheral tonometry, in pre and post Left Ventricular Assist Device (LVAD) patients.
详细描述
Pulse waveforms, especially central pressure waveforms, are predictive of cardiovascular events. Peripheral waveforms have been correlated to central waveforms. Peripheral waveforms can be easily measured through applanation tonometry. In this study the investigators hypothesize:
- That previously established peripheral tonometry techniques would apply to patients with advanced heart failure, including continuous flow LVADs and facilitate serial evaluation of central hemodynamics without invasive monitoring.
- That temporary changes in LVAD speed will be evident in frequency spectrum analysis of peripheral, non-invasive waveforms.
- That clinical events involving LVAD will have characteristic frequency spectra.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •18 years of age or older
- •Advanced heart failure as defined by need for IABP or LVAD
- •One or more of the following:
- •Current inpatient heart failure treatment with intra-aortic balloon pump (IABP)-IABP Group
- •≤ 1 week post-LVAD implantation with current IABP support-IABP/LVAD Group
- •≥ 3 mo post-LVAD placement and scheduled for LVAD speed optimization with echocardiography.-Post-LVAD Group
- •Post-LVAD placement with suspected GI hemorrhage or LVAD thrombosis-LVAD Event Group
- •Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
排除标准
- •Clinical status will not permit pause of IABP (IABP and IABP/LVAD Groups)
- •Unable to undergo echo or oversewn or patched aortic valve (Post-LVAD Group)
结局指标
主要结局
Observation of pulse wave signatures in LVAD patients
时间窗: ongoing
次要结局
未报告次要终点
研究者
研究点 (1)
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