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临床试验/NCT05478213
NCT05478213招募中不适用

Ventricular Tachycardia Substrate Mechanisms Revealed by Local Repolarization and Conduction Parameters

Emory University3 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年10月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
10
试验地点
3
主要终点
Waveform Morphology

研究概览

简要总结

The purpose of this study is to understand why certain hearts have ventricular arrhythmias and help identify areas of the heart that cause arrhythmias. There is still a significant gap in understanding why ventricular arrhythmias occur. This study will examine the electrical properties of the heart tissue to understand how these arrhythmias occur, and hopefully identify areas that might lead to ventricular arrhythmias. The hope is that studying this might be able to improve outcomes during ventricular tachycardia (VT) ablations.

详细描述

Ventricular tachycardia (VT) ablation remains the cornerstone treatment for drug refractory VT. Previous studies have reported success rate of VT ablation ranging from 23 to 49%. Despite improvements in mapping and catheter technology, there is a high recurrence rate and numerous patients who fail VT ablation.

Reasons for failure in VT ablation include the inability to identify critical areas of myocardium responsible for VT and hemodynamic instability of VT during mapping. Several studies have attempted to study electrical properties of cardiac tissues to identify potential circuits in sinus rhythm avoid mapping during unstable VT. This includes mapping fractionated electrical potentials, isochronal late activation mapping (ILAM), and ablation of low voltage regions. However, these techniques have yielded modest improvement in success rates with poor specificity of identifying important regions.

Monophasic action potentials (MAP) demonstrate cellular action potential of the myocardium. Recent evidence suggests that changes in MAP morphology can predict sudden cardiac death by ventricular arrhythmias. However, cellular activation has not been studied in VT. The researchers of this study propose that MAP signals can better elucidate electrophysiological characteristics of the myocardium, and thus identify sites critical to VT.

During a standard of care VT ablation, the researchers will use the MAP catheter to study cellular action potential of the ventricular myocardium, which cannot be done on traditional catheters. The design of this catheter is similar to other diagnostic catheters that are currently used for VT ablation. The MAP catheter is a bipolar catheter, two with electrical poles at the distal tip. The catheter is placed on the myocardium (similar to other traditional catheters) and a recording signal is transmitted to the workstation. Using the MAP catheter the will not interrupt or distort any of the standard treatment procedures.

研究设计

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

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

  • Diagnosis of ischemic cardiomyopathy
  • Single or dual chamber implantable cardioverter-defibrillator (ICD)

排除标准

  • Non-Ischemic cardiomyopathy
  • Contraindication to catheter ablation
  • Severe peripheral arterial disease or medical condition that prohibit arterial access
  • Ventricular tachycardia (VT) or sudden cardiac arrest (SCA) within 30 days of acute coronary syndrome or within 90 days of coronary revascularization

研究组 & 干预措施

Monophasic Action Potential (MAP) Catheter

Experimental

Participants undergoing ventricular tachycardia ablation per standard of care will also have cellular action potential of the ventricular myocardium assessed with the MAP catheter.

干预措施: Monophasic Action Potential (MAP) Catheter (Device)

结局指标

主要结局

Waveform Morphology

时间窗: During ablation on Day 1

Identification of sites that are critical to reentry of ventricular tachycardia from bystander sites will be performed by analyzing local ventricular activation. Local ventricular action is assessed with waveform morphology and is measured in voltage (mV). The normal range is \>3 mV bipolar and \>8.3 mV unipolar.

Conduction Velocity

时间窗: During ablation on Day 1

Identification of sites that are critical to reentry of ventricular tachycardia from bystander sites will be performed by analyzing electrophysiological properties. Electrophysiological properties are assessed with conduction velocity, measured in meters per second (m/s).

次要结局

  • Identify surrogate markers(During ablation on Day 1)
  • Identify mechanisms of slowed conduction at ILAM(During ablation on Day 1)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Neal Bhatia

Assistant Professor

Emory University

研究点 (3)

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