Impact of Atrio-ventricular Optimization With His Bundle Pacing on Treatment of Atrio-ventricular Dromotropathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Changes in left ventricular stroke volume
研究概览
简要总结
This study aims to determine the clinical and hemodynamic benefit of atrio-ventricular (AV) resynchronization with His bundle pacing in patients with symptomatic first degree AV block.
详细描述
The term AV dyssynchrony was introduced by Salden F. and coauthors in 2018. It stands for the adverse effects of AV dyssynchrony due to PR interval prolongation. According to the ESC and ACC guidelines, severe first degree AV block is an IIa indication for permanent pacemaker implantation, yet data on these patients' clinical outcomes are scarce. To independently determine the impact of AV resynchronization, His bundle pacing will be used to avoid intraventricular desynchronization.
Symptomatic patients with severe first-degree AV block and echocardiographically proven AV dyssynchrony will be included in the study.
All patients will receive a dual-chamber pacemaker with an atrial lead positioned in the right atrium and ventricular lead placed on the bundle of His. In a single-blind cross-over design, patients will be randomized to AV sequential His bundle pacing with echo-guided AV optimization or back-up VVI pacing mode. Each study period will last for three months. At the end of both periods, cardiopulmonary exercise testing, complete echocardiographic study, and clinical evaluation will be performed.
Peak oxygen uptake and echocardiography-based hemodynamic parameters in both periods will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •First OR second degree Mobitz type 1 atrioventricular block with a PR interval > 250 ms
- •left ventricular ejection fraction > 50%
- •echocardiographic criteria of atrioventricular dyssynchrony (diastolic filling time/RR interval ratio < 0,4 OR fusion of E and A waves OR diastolic mitral regurgitation)
- •symptoms on exertion (dyspnea, palpitations)
- •insufficient shortening of PR interval during exercise (PR interval > 200 ms at heart rate of 100 beats per minute)
排除标准
- •left ventricular ejection fraction < 50%
- •third degree atrioventricular block
- •atrial fibrillation
- •sinus node disease
- •left bundle branch block
- •right bundle branch block
- •ventricular arrhythmia that indicates implantation of cardioverter defibrillator
- •consumption of drugs that influence atrioventricular conduction
- •active bacterial infection
- •inability to undergo cardiopulmonary exercise test
- •anaemia (haemoglobin concentration < 100 g/L)
- •pregnancy
结局指标
主要结局
Changes in left ventricular stroke volume
时间窗: Baseline, 3 months, 6 months
Measured by echocardiography
Changes in quality of life using the 5 level EQ-5D questionnaire
时间窗: Baseline, 3 months, 6 months
EQ-5D is a standardized measure of health status consisting of 2 pages - the EQ-5D descriptive system (descriptive system with five levels) and the EQ visual analog scale ranging from 0 (worst state) to 100 (best state).
Changes in exercise capacity
时间窗: Baseline, 3 months, 6 months
Measured by peak oxygen consumption on cardiopulmonary exercise test
次要结局
- Changes in left atrial volume(Baseline, 3 months, 6 months)
- Changes in left ventricular volume(Baseline, 3 months, 6 months)
- Changes in the measure of left ventricular mechanical dyssynchrony(Baseline, 3 months, 6 months)
- Changes in lead impedance(Baseline, 3 months, 6 months)
- Fluoroscopy time(Baseline)
- Changes in sensing of R wave(Baseline, 3 months, 6 months)
- Adverse events(through study completion, an average of one year)
- Changes in QRS complex width(Baseline, 3 months, 6 months)
- Changes in pacing thresholds(Baseline, 3 months, 6 months)
研究者
Anja Zupan Mežnar
Principal Investigator
University Medical Centre Ljubljana