Prevention of Inappropriate Therapies and Serious Adverse Cardiac and Cerebrovascular Events With a Single Chamber Implantable Cardioverter Defibrillator (ICD) With DX Floating Dipole Detection. PREVENT DX
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 462
- 试验地点
- 16
- 主要终点
- The combined rate of inappropriate therapies and serious adverse cardiac and cerebrovascular events (MACCE) single-chamber devices with floating atrial dipole with the Smart function activated
研究概览
简要总结
Prevention of inappropriate therapies and serious adverse cardiac and cerebrovascular events with a single chamber implantable defibrillator with DX floating dipole atrial detection
详细描述
Prospective, randomized, open-label, multicenter, international study in a population with an accepted indication for an implantable automatic defibrillator.
The main objective is to know the different values of the rates of inappropriate therapies, of serious cardiac and cerebrovascular adverse events, and of the appropriate detections in single-chamber ICD devices, with optimized programming according to the patient's arrhythmic history, using the three discrimination methods. arrhythmias: Smart, Onset and Stability, and Morphmatch.
The device under investigation is a single chamber with a floating atrial dipole for the detection of atrial signals.
Patients who are included in the study will present an indication for an automatic cardioverter-defibrillator device according to clinical practice guidelines for an ICD and who also do not have an indication for permanent stimulation in the right atrium. For this reason, the indication of patients will be those that require an ICD without the implantation of an electrode in the atrium, that is, single-chamber ICDs or DX ICDs since both, from the therapeutic point of view, are equivalent.
The centers will follow standard clinical practice to diagnose patients
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Patients with an indication of a single chamber ICD due to high risk of sudden death.
- •Patients with and without a prior history of AF.
- •Patients with indication for primary and secondary prevention.
- •Device optimized for the discrimination of supraventricular events.
- •DX device implant with single floating cable.
- •Activation of "Home Monitoring" function.
- •Over 18 years.
- •Signature of informed consent
排除标准
- •Indication for permanent atrial pacing according to current pacing guidelines.
- •Congestive heart failure grade IV.
- •Candidates for Cardiac Resynchronization Therapy.
- •Patients with a previous device.
- •Permanent Atrial Fibrillation.
- •Life expectancy less than 12 months.
- •Pregnant or lactating women.
- •Patients who are unable to understand the nature of the study.
- •Subjects with irreversible brain damage caused by pre-existing brain disease.
- •Heart transplant 6 months prior to recruitment or expected in the next 3 months.
- •Cardiac surgery 3 months prior to recruitment or planned for the next 3 months.
结局指标
主要结局
The combined rate of inappropriate therapies and serious adverse cardiac and cerebrovascular events (MACCE) single-chamber devices with floating atrial dipole with the Smart function activated
时间窗: 24 months
determine the combined rate is not less than in single-chamber devices without atrial detection using any of the supraventricular arrhythmia discrimination modalities: Onset and Stability, and Morphmatch.
次要结局
- Proportion of appropriate and inappropriate diagnoses(24 months)
- Inappropriate therapies distribution(24 months)
- Programming adjustment justification(24 months)
- Appropriate therapies by group and by indication(24 months)
- Percentage of patients with clinical AF (atrial fibrillation) versus subclinical AF (<6 minutes duration).(24 months)
- Distribution of inappropriate therapies by chosen schedule(24 months)
- Differences in events according to Onset & Stability method versus Morphmatch method(24 months)
- Triggers of Inappropriate therapies(24 months)
- Patients presenting atrial fibrillation before inclusion(24 months)
- Patients with no prior history of atrial fibrillation (AF) who have AF during study follow-up(24 months)
- General atrial load in patients with and without previous manifestation of atrial fibrillation(24 months)
- Cerebrovascular events presenting previous episodes of atrial fibrillation(24 months)