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临床试验/NCT01851889
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

Rigshospitalet, Denmark1 个研究点 分布在 1 个国家目标入组 15 人2013年4月

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.

注册库
clinicaltrials.gov
开始日期
2013年4月
结束日期
2015年10月
最后更新
10年前
研究类型
Observational
性别
All

研究者

责任方
Principal Investigator
主要研究者

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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