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临床试验/NCT04153786
NCT04153786终止不适用

Effect of Cardiac Resynchronization Therapy (CRT) on Left Ventricular Assist Device (LVAD) Function

University of California, Davis2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年11月2日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
9
试验地点
2
主要终点
LVAD pulsatility index (PI)

研究概览

简要总结

Certain patients with congestive heart failure are treated both by implantation of an LVAD, as well as implantation with a biventricular pacemaker. Both of these devices, individually, have been shown to improve the health of patients with heart failure. However, only a small number of patients have both an LVAD and a biventricular pacemaker at the same time.

Pacemakers have many different settings. However, there is little data to inform physicians which of these different settings is best for the flow of an LVAD. This study is evaluating patients who have both a biventricular pacemaker and an LVAD. Investigators will operate the pacemaker at multiple different settings and monitor the LVAD's function to determine which, if any, setting is best for the LVAD's flow.

详细描述

Cardiac resynchronization therapy (CRT) with a biventricular pacemaker has been well-validated to improve symptoms and reduce death in select patients with heart failure. In healthy adults, the two chambers of the heart which pump blood throughout the body (the left and right ventricles) activate and contract together in synchronous fashion. In certain patients with heart failure (specifically, those with a reduced ejection fraction), the left and right ventricles no longer activate and contract synchronously. CRT restores ventricular synchrony by simultaneously activating the left (LV) and right ventricles (RV) with electrical pacing.

Left ventricular assist devices (LVADs) are used to provide mechanical support to patients with more advanced, often end-stage, heart failure. In these cases, the heart's ventricles function so poorly that even despite all standard therapies (including CRT), patients experience symptoms of congestive heart failure even at rest. The LVAD suctions blood from the ventricle and propels it into the aorta, offloading the ventricle and assisting its function.

Due to the similar reasons for using each therapy, a number of patients already possess a biventricular pacemaker at the time of LVAD implantation. Individually, each intervention is known to improve both patient survival and functional status. However, there is sparse data to evaluate the effectiveness of using both devices simultaneously. Specifically, no data is yet available assessing the effect of CRT on the functional parameters of the LVAD.

This protocol will operate the biventricular pacemaker at various settings and assess for changes in the LVAD's function in response to those settings. "Fine-tuning" and identifying the ideal the pacemaker settings will maximize clinical benefit in patients with both devices.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients who have undergone implantation of both a biventricular pacemaker and LVAD who are at least three months post-LVAD implantation and who receive routine follow-up care at the UC Davis / UC San Diego Adult Arrhythmia/ Device/ LVAD clinic.
  • Potential enrollees have been directly identified by their existing medical providers in clinic, who are investigators in this study.

排除标准

  • Any patients who do not present to their routine follow-up appointment at the time of this study.
  • Any patients who have undergone LVAD placement less than three months prior to enrollment.

结局指标

主要结局

LVAD pulsatility index (PI)

时间窗: 2-5 minutes

LVAD PI reflects the contribution of the native heart's cardiac output (or "pulse") on pump flow

LVAD power

时间窗: 2-5 minutes

Power is the voltage required by the device over each cardiac cycle.

LVAD flow

时间窗: 2-5 minutes

Flow is the liters per minute (L/min) of blood moved by the device.

LVAD speed

时间窗: 2-5 minutes

LVAD speed, or revolutions per minute (RPMs) of the device, is set by providers to a fixed value.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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