OPTIMIZING DIAGNOSTICS AND THERAPY OF ARRHYTHMIA AND SYNCOPE EVENTS USING INTELLIGENT TELEMETRIC SOLUTIONS - Evaluation of Arrhythmia Treatment Efficacy
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 360
- 试验地点
- 6
- 主要终点
- Occurence of atrial fibrillation
研究概览
简要总结
The purpose of this study is to assess efficacy of prolonged Full Disclosure ECG monitoring and signal analysis using advanced GSM telemetric technology to prescribe the most appropriate treatment of arrhythmia.
详细描述
Non-invasive methods enabling long-term ECG monitoring in patients with paroxysmal symptoms, such as tachycardia or palpitations increase the probability of detecting infrequent but dangerous events with profound clinical significance. Patients with recommendation for the first catheter ablation of Paroxysmal Atrial Fibrillation in the reference center will be included in the study. Eligible patients will have 14-day telemetric ECG monitoring. Based on detected arrhythmia events, patient's medical history and available documentation the most appropriate treatment will be recommended. Patients will undergo invasive procedures of ablation or pacemaker implantation or can be treated pharmacologically. After the invasive treatment or initiation of pharmacotherapy the 14-day telemetric ECG monitoring will be repeated to assess efficacy of the treatment.
Patients with no record of arrhythmia requiring treatment during the first 14 days ECG monitoring will terminate participation in the study. The referring physician will be informed. Further diagnosis or treatment should be performed at the referring physician's center according to the best clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age - between 18 and 80 years old
- •Physician recommendation for ablation treatment of arrhythmia
- •Patient informed consent
- •Declarative and feasible compliance (patient understands basic instructions regarding device use)
排除标准
- •Inability to comply with the study protocol
- •Lack of patient cooperation
研究组 & 干预措施
Catheter ablation
干预措施: Prolonged telemetric Full Disclosure ECG recording. (Device)
Pacemaker implantation
干预措施: Prolonged telemetric Full Disclosure ECG recording. (Device)
Pharmacotherapy
干预措施: Prolonged telemetric Full Disclosure ECG recording. (Device)
结局指标
主要结局
Occurence of atrial fibrillation
时间窗: 14 days since the start of monitoring
Confirmation of indication for catheter ablation of atrial fibrillation by detection of incidence of AF event during 14 days ECG monitoring
次要结局
- Evaluation of stroke and bleeding risk factors incidence based on scores proposed in the European Society of Cardiology (ESC) guidelines: CHADS2VASC2 and HAS-BLED(14 days)
- Indication for treatment other than catheter ablation(14 days)
- Correlation of patient self assessment based on the Quality of Life questionnaire and European Heart Rhythm Association (EHRA) scale with cardiac arrhythmia occurrence.(14 days)
- Therapy efficacy analysis(14 days)