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临床试验/NCT03556189
NCT03556189Unknown不适用

Effect of Atrioventricular Optimization on Left Ventricular Function With Dual Chamber Pacemaker; Prospective Randomized Trial

Yong Seog Oh2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2015年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
70
试验地点
2
主要终点
Left ventricular ejection fraction

研究概览

简要总结

This study aims to examine the effect of atrioventricular synchrony in AV block patients who received permanent pacemaker. By achieving physiologic ventricular diastolic filling, adjustment of atrioventricular delay of pacemaker might affect the long term outcome of left ventricular function and remodelling. The investigators designed to randomize AV block patients who already have or anticipated to receive pacemaker, into two groups. Patients in intervention group undergo reprogramming AV delay of pacemaker to the best value to increase cardiac output measured by transthoracic echocardiogram and the patients in control group undergo routinely scheduled pacemaker programming. The primary endpoint is improvement of LV systolic function and the secondary endpoint is change in left ventricular volume, cardiac output, BNP, 6-minute walk capacity and NYHA class after one year.

详细描述

It is well-known that persistent right ventricular apical pacing induces left ventricular dysfunction. The most important risk factor is the ratio of ventricular pacing so the effort to reduce pacing ratio is needed. However, almost 100% ventricular pacing is inevitable in complete atrio-ventricular block patients with implanted pacemaker. Traditionally the ventricular lead of the pacemaker is positioned in right ventricular apex and previous literatures reported that such right ventricular apical pacing impedes physiological ventricular contraction and induces left ventricular contractile dysfunction in long-term. The alternative positions of ventricular lead are right ventricular outflow tract and ventricular septum but the benefits are not yet clearly prooved. Additionally, adjusting atrio-ventricular delay is reportedto affect cardiac output by altering diastolic filling. The investigators aimed to analyze the effect of AV dealy in long-term left ventricular contractile function.

Patients over 19 years old who received or anticipated to receive permanent pacemaker due to AV block are randomized to 1:1 ratio into two groups. Patients in intervention group undergo reprogramming AV delay of pacemaker to the best value to increase cardiac output measured by transthoracic echocardiogram and the patients in control group undergo routinely scheduled pacemaker programming. Patients with underlying LV systolic dysfunction or significant valvular heart disease are excluded. Six-minute walk test, BNP, transthoracic echocardiogram, NYHA class are examined at baseline and after one year.

研究设计

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

入排标准

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

入选标准

  • Received or scheduled to receive permanent pacemaker due to AV block

排除标准

  • Left ventricular ejection fraction <50% or Left ventricular end-diastolic diameter>60mm Significant valvular disease (≥mild)

研究组 & 干预措施

Experimental

Experimental

case management consists adjusting AV delay of pacemaker to achieve best cardiac output measured by trans-thoracic echocardiogram

干预措施: Case management (Device)

Control: Usual care

No Intervention

Usual care is provided with routine pacemaker interrogation.

结局指标

主要结局

Left ventricular ejection fraction

时间窗: one year after randomization

次要结局

  • Left ventricular end-systolic diameter(one year after randomization)
  • cardiac output(one year after randomization)
  • BNP(one year after randomization)
  • 6-minute walking test(one year after randomization)
  • Left ventricular end-diastolic diameter(one year after randomization)
  • NYHA class(one year after randomization)

研究者

发起方
Yong Seog Oh
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yong Seog Oh

professor

Seoul St. Mary's Hospital

研究点 (2)

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