Impact of Conduction System Pacing on Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Left ventricular ejection fraction
研究概览
简要总结
This randomized study compares the effects of conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) versus left bundle branch pacing on left ventricular remodelling in patients with reduced left ventricular ejection fraction (< 50 %) that need permanent pacemaker implantation after transcatheter aortic valve implantation (TAVI).
详细描述
Bradycardic heart rhythm disturbances are a common complication of TAVI. Patients who will develop the indication for permanent pacemaker implantation after TAVI will be randomly assigned to either the experimental (left bundle branch pacing) or conventional (right ventricular pacing in patients with LVEF ≥ 40% and cardiac resynchronization therapy in patients with LVEF < 40 %) group. The investigators will compare the left ventricular ejection fraction (primary outcome) 12 months after randomization. The investigators will also compare electrocardiographic (QRS duration), clinical (NYHA status, 6-minute walking test, handgrip test, Kansas City Cardiomyopathy Questionnaire) and laboratory (proBNP) parameters 6 and 12 months, and other echocardiographic (left ventricular systolic and diastolic diameter, signs of dyssynchrony, myocardial work) parameters 12 months after pacemaker implantation in both groups.
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
- 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
- •Indication for permanent pacemaker implantation after transcatheter aortic valve implantation (during the same hospitalization)
- •Left ventricular ejection fraction < 50 %.
排除标准
- •Unsuccessful TAVI procedure with life expectancy < 1 year
- •Ischemic cardiomyopathy with interventricular septal fibrosis (at least echocardiographic signs of fibrosis)
- •Severe kidney failure (glomerular filtration rate < 30 ml/min)
- •Previous permanent pacemaker
结局指标
主要结局
Left ventricular ejection fraction
时间窗: 12 months
次要结局
- NT-proBNP concentration(6 and 12 months)
- NYHA status(6 and 12 months)
- 6-minute walking test(6 and 12 months)
- Hand grip test(6 and 12 months)
- QRS duration(baseline, 6, and 12 months)
- Left ventricular systolic diameter(12 months)
- Left ventricular diastolic diameter(12 months)
- Global constructive work(12 months)
- Global work index(12 months)
- Global wasted work(12 months)
- Global work efficiency(12 months)
- Signs of mechanical dyssynchrony(12 months)
- Systolic pulmonary artery pressure (echocardiographic parameter)(12 months)
- The Kansas City Cardiomyopathy Questionnaire (KCCQ-12)(6 and 12 months)
研究者
Klemen Steblovnik
Principal Investigator
University Medical Centre Ljubljana