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临床试验/NCT01446796
NCT01446796终止4 期

Hemodynamic and Clinical Effects of Continuous Right Ventricular Pacing in the Early Post-operative Period After Left Ventricular Assist Device Implantation

Duke University2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2011年9月最近更新:
适应症

试验速览

阶段
4 期
状态
终止
入组人数
3
试验地点
2
主要终点
Length of Hospitalization

研究概览

简要总结

Continuous right ventricular (RV) pacing demonstrates harm in patients with normal left ventricular (LV) function as well as in patients with cardiomyopathy and clinical heart failure. However, little is known about RV pacing in patients with advanced heart failure treated with an implantable left ventricular assist device (LVAD). The univentricular support provided by contemporary continuous flow LVAD's has improved outcomes for many advanced heart failure patients, yet the incidence of RV failure in the early post-operative period following implantation is associated with significantly reduced survival and increased length of stay. Acute LVAD unloading of the left ventricle has adverse effects on RV shape and size that contribute to post-operative RV failure. By promoting RV synchrony, RV overdrive pacing may counteract these adverse mechanical alterations, improving RV systolic function and ultimately LVAD function.

The investigators will recruit all patients referred for an implantable, continuous flow LVAD at Duke University Medical Center who have an existing implantable dual-chamber cardioverter-defibrillator. Patients will be prospectively randomized into two cohorts to compare continuous right ventricular pacing vs. native ventricular conduction at equivalent heart rates. Multiple clinical outcomes will be examined over a two week period post-operatively including invasive hemodynamics, vasoactive medication use, end-organ function, RV function by Echocardiography as well as patient symptoms and functional status.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old, both men and women
  • Existing implantable cardioverter-defibrillator (ICD)
  • Referred for implantation of a continuous flow LVAD

排除标准

  • Permanent left ventricular epicardial defibrillator in place
  • Congenital heart disease with single ventricle physiology
  • Right ventricular assist device (RVAD) in place
  • Existing pacing indication

结局指标

主要结局

Length of Hospitalization

时间窗: 14 days

To determine whether continuous RV pacing reduces ICU length of stay (number of days) and overall hospital length of stay (number of days) post-LVAD implantation.

次要结局

  • Post-operative Need for Hemodynamic / Respiratory Support(14 days)
  • Right Ventricular Function(14 days)
  • Functional Capacity and Symptoms(14 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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