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临床试验/NCT07057544
NCT07057544招募中不适用

The Role of Ultra-high-frequency ECG in the Localization of Left Ventricular Conduction Disorders and Prediction of Response to Resynchronization Therapy

Faculty Hospital Kralovske Vinohrady2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Left ventricular end-systolic volume

研究概览

简要总结

The main objective of the project is to demonstrate that in patients with heart failure and QRS complex of nonRBBB morphology lasting over 130 ms, UHF-ECG can differentiate patients with trueLBBB from IVCD better than existing approaches based on the assessment of QRS complex morphology and duration from 12-lead ECG.

Another goal of the proposed study is to demonstrate that trueLBBB patients will benefit more from CRT using left bundle branch pacing than from CRT using biventricular pacing.

The final aim of the project is to demonstrate that the echocardiographic and clinical response in patients with intraventricular conduction disturbance will be dependent on the degree of reduction in ventricular dyssynchrony after CRT.

详细描述

Since the introduction of cardiac resynchronization therapy (CRT), a way to better define the patients who will benefit from it most has been sought. Their selection based on the duration of the QRS complex or its morphology fails in some of them. Current data demonstrate that CRT done by pacing the conduction system below the site of the left bundle branch block may be a better therapy than biventricular pacing. A prerequisite for a better effect of conduction system pacing is to perform it in patients in whom a conduction block is present in the left bundle branch block ("true" LBBB) and not in the patients with a more distal left ventricular conduction problem (IVCD). The criteria derived from the surface standard ECG are insufficient to differentiate "true" LBBB from IVCD, and thus it is not possible to determine the optimal treatment in some patients. The sequence of ventricular activation can be visualized within a few minutes using ultra-highfrequency ECG (UHF-ECG) in virtually all patients. It is a non-invasive method that shows ventricular dyssynchrony as a time difference between the activation of the ventricles or their individual segments. Pilot data show that patients with "true" LBBB are likely to have greater ventricular dyssynchrony and a different pattern of ventricular depolarization than patients with IVCD. The aim of this project is to test the hypothesis that UHF-ECG can distinguish "true" LBBB from IVCD in patients with heart failure and left ventricular conduction disturbance better than using standard criteria assessing QRS duration and morphology. Other aim is to demonstrate that in patients with trueLBBB resynchronization using conduction system pacing will lead to better echocardiographic and clinical outcomes than biventricular pacing. Finally, the echocardiographic and clinical response of IVCD patients will depend on the reduction of UHF-ECG ventricular dyssynchrony after CRT.

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
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

入选标准

  • HF due to ischemic or non-ischemic cardiomyopathy
  • known coronary angiography
  • NYHA II-IV
  • LVEF ≤40%
  • non-RBBB QRSd lasting >130 ms (by automated measurement)
  • proximal LBBB proved by an invasive EP study or non-invasive dyssynchrony assessment in case such a method is confirmed to be non-inferior to an invasive EP study during the project

排除标准

  • Age ˂18 years
  • heart failure from reversible causes
  • Moderate to severe aortic stenosis
  • pregnancy
  • active myocarditis
  • hypertrophic cardiomyopathy
  • cardiac valve surgery in the last three months
  • myocardial infarction, PCI, or CABG in the last three months
  • severe valvular disease requiring intervention
  • severe atherosclerotic disease of the aorta and/or femoral arteries
  • life expectancy ˂1 year
  • known medical condition or contraindication causing potential complications for EP study

结局指标

主要结局

Left ventricular end-systolic volume

时间窗: 6 and 18 months since randomization

Left ventricular end-systolic volume reduction

次要结局

未报告次要终点

研究者

发起方
Faculty Hospital Kralovske Vinohrady
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Karol Curila

MD, PhD

Faculty Hospital Kralovske Vinohrady

研究点 (2)

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