Left Bundle Branch Area Pacing in Patients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- shortening of QRS
研究概览
简要总结
The relevance of Left Bundle Branch Pacing (LBBP) lies in its potential as a promising treatment option for patients with heart failure and left bundle branch block. LBBP aims to restore the normal physiological activation of the heart by delivering electrical impulses to the anatomical area of the left bundle branch, which may lead to more effective and synchronized ventricular contractions. Compared to traditional cardiac resynchronization therapy (CRT), this can result in a more physiological correction of dyssynchrony, improvement in left ventricular pump function, reduction in left ventricular volumes, and a decrease in mitral regurgitation. A crucial criterion is the reduction of heart failure symptoms and the enhancement of the patients quality of life.
详细描述
The aim The aim of Left Bundle Branch Pacing (LBBP) research is to assess its effectiveness in improving the contractile capacity of the left ventricular myocardium. The objectives are as follows
- To determine the optimal patient selection criteria;
- To assess long-term outcomes;
- To investigate safety and complications;
- To compare selective Left Bundle Branch Pacing (LBBP) with traditional cardiac resynchronization therapy in patients with heart failure.
Materials and Methods:
Materials: The study will include patients who were hospitalized at the National Research Cardiac Surgery Center (NRCS) in Astana, Kazakhstan. The study will be a mixed-methods approach, consisting of a retrospective component and a prospective component. The retrospective part of the study will involve the analysis of clinical and functional data of patients with left bundle branch block and heart failure. The prospective part of the study will involve the evaluation of quantitative and qualitative parameters based on transthoracic echocardiography data, the functional status of patients after LBBP implantation, and the assessment of long-term outcomes of the study, including its impact on mortality, hospitalization rates, and overall prognosis.
Inclusion Criteria:
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
- 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
- •Male or female ≥ 18 years of age at Visit
- •Patients with complete left bundle branch block, QRS duration greater than 130 ms, left ventricular ejection fraction (LVEF) less than 35%, and New York Heart Association (NYHA) functional class 2-3, who have been ineffective on optimal medical therapy for at least 3 months.
- •Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
排除标准
- •Psychic disturbances.
- •Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data - life expectancy less than 1 year.
结局指标
主要结局
shortening of QRS
时间窗: From enrollment to the end of follow-up period at 12 months
Efficacy will be evaluated by shortening of QRS duration on ECG.
Improvement of left ventricle ejection fraction
时间窗: From enrollment to the end of follow-up period at 12 months
Efficacy will be evaluated by increasing of left ventricle ejection fraction, measured by transthoracic echocardiography in 4 chamber apical position by Simpson's approach.
Decreasing of left ventricle end-diastolic diameter
时间窗: From enrollment to the end of follow-up period at 12 months
Efficacy will be evaluated by decreasing of left ventricle end-diastolic diameter measured by transthoracic echocardiography in parasternal long axis.
General complications related to implantable cardiac device
时间窗: From enrollment to the end of follow-up period at 12 months
Incidence and amount of participants with general complication (deaths, stroke, thromboembolic complications);
LBBAP lead-related complications complications related to implantable cardiac device
时间窗: From enrollment to the end of follow-up period at 12 months
Incidence and amount of patients with LBBAP lead-related complications (intraprocedural perforation into the left ventricle (LV) cavity , delayed perforation into the LV cavity, acute chest pain, acute ST-segment elevation in multiple leads, acute coronary syndrome, coronary vein fistula, coronary artery fistula, painful pacing/chest pain, right bundle branch injury, LBBAP lead unscrewable/trapped/damaged helix, LBBAP lead dislodgement, threshold rise to an absolute value \> 2 V, threshold rise \> 1 V from baseline, threshold rise leading to re-intervention)
Decreasing of left ventricle end-diastolic volume
时间窗: From enrollment to the end of follow-up period at 12 months
Efficacy will be evaluated by decreasing of left ventricle end-diastolic volume measured by transthoracic echocardiography in apical 4-chamber position
procedure-related complications related to implantable cardiac device
时间窗: From enrollment to the end of follow-up period at 12 months
Incidence and amount of participants with procedure-related complication (pneumothorax, pocket/wound infection, systemic infection, pocket hematoma, atrial lead dislodgement, pericardial effusion, large vein thrombosis, re-intervention for other non-LBBAP lead reasons, subclavian arteriovenous fistula after puncture)
Decreasing of left ventricle end-systolic volume
时间窗: From enrollment to the end of follow-up period at 12 months
Efficacy will be evaluated by decreasing of left ventricle end-systolic volume measured by transthoracic echocardiography in apical 4-chamber position
Improvement of mitral regurgitation
时间窗: From enrollment to the end of follow-up period at 12 months
Efficacy will be evaluated by decreasing of mitral regurgitation measured by transthoracic echocardiography in multiply positions
次要结局
未报告次要终点