Conduction System Pacing to Preserve Left Ventricular Function in Patients Requiring Permanent Ventricular Pacing: The PRESERVE-CSP Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Left ventricular ejection fraction at 6 months
研究概览
简要总结
The purpose of this randomized, open-label trial was to determine whether permanent conduction system pacing preserves left ventricular function and reduces the incidence of pacing-induced cardiomyopathy compared with conventional right ventricular apical pacing in patients with preserved LVEF who required permanent ventricular pacing for atrioventricular block and were considered at increased risk because of structural heart disease and/or a wide native QRS complex.
详细描述
Eligible participants had an LVEF above 50%, an indication for permanent pacemaker implantation due to atrioventricular block, an anticipated ventricular pacing burden above 85%, and either underlying structural heart disease or a native QRS duration above 120 ms. After written informed consent, participants were randomized to conduction system pacing or right ventricular apical pacing. Clinical, electrocardiographic, echocardiographic, functional, quality-of-life, and biomarker assessments were performed at baseline and at 6 months as specified in the protocol. Subsequent routine pacemaker-clinic follow-up was used to ascertain clinical events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left ventricular ejection fraction greater than 50% by the Simpson four-chamber method before pacemaker implantation.
- •Indication for permanent pacemaker implantation due to atrioventricular block.
- •Anticipated ventricular pacing burden greater than 85%.
- •At least one of the following high-risk features: structural heart disease or native QRS duration greater than 120 ms.
- •Structural heart disease was defined as previously diagnosed ischemic heart disease, with or without prior myocardial infarction, and/or at least moderate left-sided valvular stenosis or regurgitation, and/or an aortic or mitral valve prosthesis.
- •Provision of written informed consent.
排除标准
- •Failure to meet all inclusion criteria.
- •Refusal or inability to provide written informed consent.
- •Dementia or significant cognitive impairment.
- •Underlying systemic disease associated with a life expectancy of less than 1 year.
研究组 & 干预措施
Right Ventricular Apical Pacing
干预措施: Right Ventricular Apical Pacing (Procedure)
Conduction System Pacing
干预措施: Conduction System Pacing (Procedure)
结局指标
主要结局
Left ventricular ejection fraction at 6 months
时间窗: 6 months after pacemaker implantation
Left ventricular ejection fraction (LVEF), measured by transthoracic echocardiography using the Simpson method and expressed as a percentage, compared between the conduction system pacing and right ventricular apical pacing groups.
Pacing-induced cardiomyopathy at 6 months
时间窗: 6 months after pacemaker implantation
Pacing-induced cardiomyopathy was defined as an absolute decrease in LVEF of more than 10 percentage points from baseline resulting in an LVEF below 50%, in the absence of an alternative cause, compared between study groups.
次要结局
- Absolute change in left ventricular ejection fraction, in percentage points(Baseline to 6 months)
- Minnesota Living with Heart Failure Questionnaire score(6 months)
- Six-minute walk distance (meters)(6 months)
- NT-proBNP concentration(Baseline and 6 months)
- Heart failure hospitalization(Through study follow-up (6 months))
- All-cause and cardiac mortality(Through study follow-up (6 months))
- Failure of conduction system pacing (Safety)(Through study follow-up (6 months))
- Failure due to ventricular lead dislodgement or an increase in pacing threshold above 2.5 V at 1 ms.(Through study follow-up (6 months))