跳至主要内容
临床试验/NCT00604110
NCT00604110Unknown3 期

Interest in Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2008年2月1日最近更新:
适应症

试验速览

阶段
3 期
发起方
入组人数
12
试验地点
1
主要终点
Determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular will improve the heart function

研究概览

简要总结

Patients with reduced left ventricular function are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. A significant portion of these patients require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious The aim of this study is to determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (EF≤ 45%), is hemodynamically favourable.

详细描述

Some patients with left ventricular systolic dysfunction (LVSD) have an inefficient pumping function. These patients have been shown to benefit from a device therapy known as biventricular pacing. Biventricular pacing causes a more coordinated contraction of the heart chambers resulting in improvement in the pumping ability of the heart and blood pressure. Cardiac Resynchronization Therapy (CRT) has established itself as a proven therapy for congestive heart failure in adults, patients showing improvement in exercise tolerance, quality of life, and survival.

In cardiac surgery, a significant number of these patients with left ventricular systolic dysfunction require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious Whether biventricular pacing in patients with LVSD improves patient outcomes after heart surgery has not been investigated.

The aim of this crossover trial is to compare conventional ventricular pacing and DDD-biventricular in post operative patients with a pre operative ejection fraction less than 45%, in a prospective randomized setting.

We would like to determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular, immediately after heart surgery in patients with LVSD will improve the heart function.

Immediately after surgery, the patients will receive atrio ventricular conventional right ventricular pacing, or biventricular pacing depending upon the treatment arm that they were randomized to.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
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
否

入选标准

  • •Planned CABG and/or valve surgery
  • •Left ventricular dysfunction (EF≤ 45%)
  • •Age > 18 years
  • •able to give written information consent

排除标准

  • •Existing permanent pace maker
  • •Atrial fibrillation
  • •Enrolment in other research protocols
  • •Inability to give written informed consent
  • •Heart transplant
  • •Pre operative cardiovascular instability

结局指标

主要结局

Determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular will improve the heart function

时间窗: immediately after heart surgery in patients with LVSD

次要结局

未报告次要终点

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other

研究点 (1)

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