The Pacing in Atrioventricular Block: a Comparative Evaluation of Central Haemodynamics, Cardiac Function, and Quality of Life
概览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Central systolic blood pressure
概览
简要总结
A randomized, single-blind study comparing two pacing strategies in patients with atrioventricular block requiring permanent pacemaker implantation. This trial evaluates the impact of conduction system pacing (left bundle branch area pacing) versus standard right ventricular pacing on central hemodynamics, cardiac function, and patient quality of life over 12 months. The study will enroll 124 patients from two Estonian tertiary hospitals and measure central systolic arterial pressure as the primary outcome, with secondary assessments of arterial stiffness, echocardiographic parameters, electrical activation patterns, and quality of life scores.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80 years
- •Diagnosis of atrioventricular block
- •Expected survival \>1 year
排除标准
- •Reduced left ventricular ejection fraction (EF \<45%)
- •Expected ventricular pacing burden \<20%
- •Inter-arm systolic blood pressure difference \>15 mmHg
- •Percutaneous coronary intervention or coronary artery bypass surgery within the last 30 days
- •Secondary hypertension
- •Orthostatic hypotension
- •Clinically significant valvular heart disease
- •Congenital heart disease
- •Pulse wave analysis or pulse wave velocity measurement cannot be reliably performed
- •Pregnancy or breastfeeding
研究组 & 干预措施
Conduction system pacing
干预措施: Conduction system pacing (Device)
Right ventricular pacing
干预措施: Right ventricular pacing (Device)
结局指标
主要结局
Central systolic blood pressure
时间窗: One year post implantation of pacemaker
次要结局
未报告次要终点
研究者
Silver Heinsar
Clinical researcher
University of Tartu