Ultra-high-frequency ECG for Prediction of Adverse Left Ventricular Remodeling in Permanent Right Ventricular Pacing
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 368
- 试验地点
- 1
- 主要终点
- negative remodeling prediction
研究概览
简要总结
The main goal of the project is to prove that ultra-high-frequency ECG (UHF-ECG) can be used as a diagnostic tool that allows the prediction of patients susceptible to the negative effect of right ventricular myocardial pacing. The prediction will be based on the assessment of electrical dyssynchrony and local depolarization durations of left ventricular depolarization emerging during right ventricular pacing. If proved to be valid in left ventricular negative remodeling prediction, UHF-ECG-derived parameters of ventricular dyssynchrony could be used as markers allowing a lead placement optimization during an implant procedure. This information can help the operator to identify patients with the urgent need for physiological pacing (HB or LBBp) and patients in which a right ventricular myocardial pacing is sufficient and will not lead to the development of the negative left ventricular remodeling.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •expectation of permanent right ventricular pacing with atrio-ventricular delay set to 150/180 ms (130/160 resp.) for sensed/paced atrial events during a follow-up,
- •a good quality of images during echocardiography,
- •willingness to attend clinical check-ups in the implanting center for at least two years.
- •life expectancy of at least 2 years
排除标准
- •planned cardiac surgery or transcatheter aortic valve implantation
- •hypertrophic cardiomyopathy
- •an indication for implantable cardioverter-defibrillator, biventricular implantable cardioverter-defibrillator, or biventricular pacemaker
- •active myocarditis
- •cardiac surgery or coronary revascularization in the last ten days
- •persistent/permanent atrial fibrillation during randomization
- •severe aortic stenosis
- •mitral valvular disease with an indication to intervention.
结局指标
主要结局
negative remodeling prediction
时间窗: 1 year from randomization
* 5% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG electrical dyssynchrony parameter * 5% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG left ventricular lateral wall delay parameter * 5% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG V6d parameter * 10% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG left ventricular lateral wall delay parameter * 10% drop in the left ventricular ejection fraction will be predicted by the duration of UHF-ECG V6d parameter
次要结局
- RV myocardial to physiological pacing comparison(2 years from randomization)
- UHF-ECG prediction of clinical outcome(3 years from randomization)
研究者
Karol Curila
Principal investigator
Faculty Hospital Kralovske Vinohrady