Physiologic Cardiac Pacing to Prevent Left Ventricular Dysfunction Post Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Heart Failure Hospitalization
研究概览
简要总结
The study aims to compare permanent Conduction System Pacing (CSP) with the standard therapy - Right Ventricular Pacing (RVP) or Biventricular Pacing (BVP) - in preventing the development and progression of symptomatic Chronic Heart Failure (CHF) and improving survival in patients after Transcatheter Aortic Valve Implantation (TAVI).
详细描述
A multicenter randomized controlled head-to-head trial was planned to compare the effects of permanent pacemaker implantation (PPMI) using CSP (study intervention) with currently standard therapy - RVP or BVP (control group). The study population will consist of patients hospitalized after TAVI complicated with high-degree persistent atrioventricular (AV) block or newly developed complex AV or intraventricular conduction disturbances, qualified for PPMI within 30 days after surgery, following the 2021 European Society of Cardiology (ESC) guidelines on cardiac pacing and cardiac resynchronization therapy.
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
- Single (Participant)
盲法说明
Patient will be blind to type of intervention. Due to a need of method-specific use of hardware and tailored programming of cardiac devices, medical staff is impossible to blind. The inability to blind affects also echocardiographists and anyone performing device interrogation as significant differences in number and localisation of pacing leads, their electrical parameters and pacemaker settings are inherently different in studied arms.
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
- •transcatheter aortic valve implantation (TAVI) in up to 30 days before qualification to pacemaker implantation
- •Fulfilled criteria for permanent pacemaker implantation according do 2021 ESC guidelines
- •Written informed consent
- •Age of at least 18 years
排除标准
- •Permanent pacemaker implantation before TAVI procedure
- •The occurrence of conduction disturbances more than 30 days after TAVI procedure
- •No written informed consent
- •Inability to obtain informed consent from participant
- •Predicted inability to obtain cooperation from patient during observation period
研究组 & 干预措施
Conduction System Pacing
Patients who receive Conduction System Pacing in form of Left Bundle Branch Area Pacing or His Bundle Pacing.
干预措施: conduction system pacing (Device)
Standard Pacing Method
Patients who receive currently standard pacing method with exact type of ventricular pacing depending upon left ventricular ejection fraction (LVEF): right ventricular pacing in case of LVEF >= 40% or biventricular pacing if LVEF is determined to be less than 40%, as per current ESC guidelines.
干预措施: right ventricular or biventricular pacing (Device)
结局指标
主要结局
Heart Failure Hospitalization
时间窗: 12 months
Hospitalization due to heart failure as a main reason
All-cause death
时间窗: 12 months
Death from any cause
次要结局
- Pacing-Induced Cardiomyopathy (PICM)(24 months)
- Change in global longitudinal strain (GLS)(24 months)
- Change in the concentration of the N-terminal pro-brain natriuretic peptide (NT-proBNP)(24 months)
- Change in Quality of Life(24 months)
- Atrial Fibrillation (AF) episodes(24 months)
- Change in exercise capacity(24 months)
- Response to Cardiac Resynchronization Therapy (CRT)(24 months)
- Atrial High Rate Episodes (AHRE) in pacemaker recordings(24 months)