NCT01851889
已完成
不适用
Optimizing Continuous-flow Left Ventricular Assist Device Settings and Identification of Pump Malfunction - A Comparative Study of Echocardiography and Invasive Hemodynamics
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Heart Failure.
- 发起方
- Rigshospitalet, Denmark
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Pulmonary capillary wedge pressure in mmHg.
- 状态
- 已完成
- 最后更新
- 10年前
概览
简要总结
The purpose of the trial is to identify factors which can be used as guidance when optimizing continuous-flow left ventricular assist device (CF-LVAD) settings.
The hypothesis of the study is that pulmonary capillary wedge pressure (PCWP) will change independently of left ventricular end diastolic diameter (LVEDD) when increasing pump speed ie ΔPCWP/RPM ≠ ΔLVEDD/RPM.
The primary combined endpoint of the study is correlation between ΔPCWP and LVEDD slope under ramp testing in a cohort of "continuous-flow left ventricular assist device" heart failure patients.
研究者
Finn Gustafsson
DMSc, Ph.d., Chief Physician.
Rigshospitalet, Denmark
入排标准
入选标准
- •Heart failure patients with HeartMate II (HM II) followed as outpatients at The Heart Centre at University Hospital of Copenhagen, Rigshospitalet.
- •Age \> 18 years.
- •Heart failure in stable phase without the need for intravenous inotropic therapy.
- •Ischemic or non-ischemic cardiomyopathy.
- •Signed informed consent.
排除标准
- •Unstable patients with the need for intravenous inotropic therapy.
- •Current hospitalization.
- •Implantation of HM II less than one month ago.
结局指标
主要结局
Pulmonary capillary wedge pressure in mmHg.
时间窗: On trial day.
研究点 (1)
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