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临床试验/NCT01290822
NCT01290822终止1 期

Optimized Biventricular Pacing in Allograft Recipients

Henry M. Spotnitz1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2007年1月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
终止
发起方
入组人数
12
试验地点
1
主要终点
Cardiac Output

研究概览

简要总结

This study tests optimization of biventricular pacing (BiVP) in patients with dilated cardiomyopathy (DCM) or ischemic cardiomyopathy (ICM) during cardiac transplantation in patients with advanced cardiac failure. It examines the effects of atrioventricular delay (AVD), interventricular delay (VVD or RLD), and left ventricular pacing site (LVPS) on cardiac output (CO). BiVP results are compared to traditional atrial (AAI) pacing at an identical heart rate.

详细描述

This study is designed to increase the benefit of biventricular pacing (BiVP), which is an established therapy for advanced heart failure. The investigators will test 6 left ventricular (LV) pacing sites and 16 timing sequences in the operating room just before cardiac transplant. Pacing will be implemented after patients have been anticoagulated and connected to the heart-lung machine. Pacing by previously implanted pacemakers will be suppressed. The investigators will measure cardiac output (CO) by aortic flow probe (AFP), left ventricular (LV) contractility by a combination of trans-septal pressure gradients, and simultaneous left ventricular pressure (LVP)and transesophageal echocardiography (TEE) during transient reduction of inflow of blood to the heart by vena caval occlusion. The goal is to prove that this optimization will increase the amount of blood pumped by the failing heart by 15% as compared with standard atrial (AAI) pacing. The testing protocol is 12.5 minutes in duration, and the entire protocol should be executable in 20 minutes. Care will not be altered otherwise. Results will improve management of the general population of patients with advanced heart failure while minimally increasing the risk to patients undergoing cardiac transplantation. Benefits of this study should include: improved patient selection for BiVP and a decrease in the presently recognized 30-40% incidence of BiVP nonresponders.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •New York Heart Association (NYHA) heart failure class III/IV
  • •Left Ventricular Ejection Fraction (LVEF) <36%
  • •QRS >120 msec

排除标准

  • •Intracardiac shunts
  • •Sinus tachycardia >120 bpm
  • •Second or third degree heart block
  • •Previous cardiac surgery
  • •Mechanical circulatory assistance
  • •Atrial fibrillation

研究组 & 干预措施

BiVP Pacing

Experimental

BIVP optimize AVD, VVD, and LVPS parameters and assess the effect on cardiac output.

干预措施: BiVP (Device)

AAI Pacing

Active Comparator

Traditional atrial (AAI) pacing

干预措施: AAI Pacing (Device)

结局指标

主要结局

Cardiac Output

时间窗: 13 minutes of testing; performed before CPB for allograft receipt

The primary endpoint of this study compares cardiac output between AAI pacing and optimal BiVP for DCM and ICM groups separately.

次要结局

  • Interatrial Delay (Between Right Atrium and Left Atrium)(13 minutes of testing; performed before CPB for allograft receipt)
  • Peak LV dP/dt(13 minutes of testing; performed before CPB for allograft receipt)
  • Peak RV dP/dt(13 minutes of testing; performed before CPB for allograft receipt)
  • Interventricular Synchrony(13 minutes of testing; performed before CPB for allograft receipt)
  • Atrial Latency(13 minutes of testing; performed before CPB for allograft receipt)

研究者

发起方
Henry M. Spotnitz
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Henry M. Spotnitz

George H. Humphreys, II Professor of Surgery

Columbia University

研究点 (1)

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