Electrical and Hemodynamic Assessment of Pacing Modalities in Patients With Indications for Cardiac Resynchronization Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- QRSd
研究概览
简要总结
Heart failure patients with delayed electrical activation of the heart often benefit from cardiac resynchronization therapy (CRT). However, traditional CRT using biventricular pacing is not effective in all patients. This study aims to evaluate the acute effects of pacing at different sites within the heart's conduction system-including His bundle pacing, deep septal pacing, left ventricular septal pacing, non-selective left bundle branch pacing, and selective left bundle branch pacing.
We will assess how these pacing strategies improve electrical synchrony and heart function by analyzing ECG parameters, such as QRS duration and QRS area, and measuring hemodynamic response using left ventricular pressure changes. The goal is to identify which pacing site provides the best improvement in heart performance. The study includes patients with left bundle branch block or intraventricular conduction delay, reduced heart function (ejection fraction <35%), and prolonged QRS duration (>150 ms).
This research may help improve the effectiveness of pacing therapy in heart failure patients who are not responding well to current CRT methods.
详细描述
This is a prospective, single-center, crossover study designed to evaluate the acute hemodynamic and electrical effects of pacing at five distinct sites within the conduction system in patients with heart failure and wide QRS complexes. Each participant will undergo temporary pacing at the His bundle, deep septal, left ventricular septal, non-selective left bundle branch, and selective left bundle branch sites.
Pacing sites will be confirmed by fluoroscopic guidance and intracardiac electrogram criteria, including stimulus-to-R' interval and QRS morphology. Hemodynamic response during each pacing mode will be assessed non-invasively using a Finometer device, which continuously measures beat-to-beat blood pressure and provides derived parameters of cardiac function.
The primary objective is to compare the relative hemodynamic benefits and electrical synchrony achieved at each pacing location, with the aim of optimizing lead placement strategies for conduction system pacing in heart failure patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NYHA class I to ambulatory IV despite optimized medical therapy for ≥3 months, LVEF ≤35%, and sinus rhythm with LBBB. LBBB was defined as QRS duration ≥130 ms, QS or rS in lead V1, broad/notched R waves in leads I, aVL, V5-V6, and absence of q waves in V5-V6
排除标准
- •second- or third-degree AV block, frequent PVCs, moderate-to-severe aortic stenosis, LV thrombus, or significant peripheral vascular disease
结局指标
主要结局
QRSd
时间窗: within 30 minutes per patient
QRSd was measured from the onset to the end of the QRS complex
QRSa
时间窗: within 30 minutes per patient
QRSa was computed as the sum of the QRS area across three orthogonal vectorcardiographic leads reconstructed using the Kors transformation matrices
Hemodynamic Evaluation
时间窗: within 30 minutes per patient
Continuous non-invasive blood pressure was monitored using a Finometer device
次要结局
未报告次要终点
研究者
Yixiu Liang
Professor, Chief Physician
Shanghai Zhongshan Hospital