Evaluation of conTempoRary Cardiac Stimulation in Clinical practicE: lEft, BivEntriculAr, Right, and conDuction System Pacing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 8,400
- 试验地点
- 31
- 主要终点
- All cause death at 12 months
研究概览
简要总结
The goal of this observational study is to evaluate the clinical characteristics of patients undergoing permanent cardiac pacing and to compare procedural efficacy and safety of different implantation approaches in the clinical practice of the participating centres. The contribution of non-fluoroscopic anatomical and electrophysiological reconstruction systems to device implantation procedures will also be evaluated.
Participants [patients over 18 years old with an indication to receive a definitive pacemaker/intracardiac defibrillator implant] will receive a permanent cardiac pacing implant as requested according to European Society of Cardiology (ESC) guidelines; the investigators will evaluate procedural efficacy and safety of different implantation approaches.
详细描述
Cardiac pacing with implantable electronic cardiac devices and transvenous leads has been introduced since 1960 and is considered a safe, effective and low-risk therapy. The most common indications for permanent cardiac pacing are sinus node dysfunction and atrioventricular blocks. In Europe, pacemaker implants exceed 1000 per million inhabitants. The aim of this therapy is not only to improve patients survival but also their quality of life, which is an essential aspect in assessing patients clinical status and prognosis.
Nowadays, five types of cardiac pacing are recognised in clinical practice:
- Endocardial right chambers pacing: the device is implanted in the subcutaneous subclavian area and it is connected to transvenous leads implanted in the right cardiac chambers, which detect intrinsic electrical activity and stimulate when needed;
- Epicardial pacing: this procedure is often performed in conjunction with cardiac surgery;
- Cardiac resynchronisation therapy (CRT): it delivers biventricular or left ventricular pacing in order to correct interventricular electromechanical dyssynchrony and to improve cardiac output;
- Conduction system pacing: it stimulates the His bundle or the left bundle branch area downstream of the conduction block, in order to restore a physiological electromechanical activation.
- Leadless pacing: via a percutaneous approach through a large-calibre vein, leadless device is placed inside the right ventricle.
These pacing modalities have different possibilities to restore a normal cardiac electromechanical activation, resulting in different degrees of mechanical efficiency in terms of systolic output and diastolic pressures, with consequent effects on improvement/onset of heart failure and cardiopulmonary performance of our patients.
Right ventricular pacing induces a dyssynchronous cardiac activation pattern that can lead to left systolic dysfunction and a consequent increased risk of death related to the development of heart failure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 cardiac stimulation
- •Having performed the implantation of a device for cardiac stimulation
排除标准
- •Age < 18 years;
- •Pregnancy status;
结局指标
主要结局
All cause death at 12 months
时间窗: 12 months
The investigators will monitor patient's all causes death
30 days efficacy
时间窗: 30 days
Number of successful implantations, defined as the achievement of the planned pacing modality
Rate of hospitalizations for heart failure at 12 months
时间窗: 12 months
The investigators considered the worsening of heart failure requiring hospital management
次要结局
- Onset/worsening of heart failure(120 months)
- Lead dislocation rate(120 months)
- Lead fracture rate(120 months)
- Onset/worsening of ventricular tachyarrhythmias(120 months)
- Radiation exposure(implantation procedure)
- Success rate of CRT in heart failure(120 months)
- Pneumothorax rate(30 days)
- Hemothorax rate(30 days)
- Pocket hematoma rate(30 days)
- Fluoroscopy time(implantation procedure)
- Pericardial effusion rate(30 days)
- All cause and cardiovascular death at 1, 3, 5, 10 years(120 months)
- Onset/worsening of atrial tachyarrhythmias(120 months)
- Procedural time(implantation procedure)
- Cardiac perforation rate(30 days)
- Cardiac Implantable Electronic Devices infections rate(120 months)
- Reintervention rate(120 months)
研究者
Matteo Bertini
Professor
University Hospital of Ferrara