Catheter Ablation of Arrhythmias With High Density Mapping System in the Real World Practice. The CHARISMA Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Percentage of patients with arrhythmia recurrences
研究概览
简要总结
The CHARISMA study is a non-randomized, multicenter, prospective study in which consecutive patients indicated for arrhythmia will be enrolled.
Patients can be treated with any market released catheter for ablation and diagnostic examination. The decision to perform the ablation will be made based on clinical evaluation of the investigators according to their clinical practice. The study does not require specific surgical techniques. The study has been designed to describe the Italian clinical practice in relation to the ablation approach of different kind of arrhythmias. In particular, the investigators will analyze the percentage of acute and long-term success in clinical practice, predictors of arrhythmias recurrence and they will describe the methods for the validation of ablation success, the techniques adopted, and the patient management approaches in the participating centers
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are eligible for ablation procedure of atrial and ventricular arrhythmia;
- •Patients who are able to sign an authorization to use and disclose health information and capable of providing informed consent.
- •Patients who are willing and capable to attend scheduled follow-up visits at the clinical investigational center for at least 12 months
排除标准
- •Patients who are currently enrolled in another clinical study that would directly interfere with the clinical practice of the investigational center
结局指标
主要结局
Percentage of patients with arrhythmia recurrences
时间窗: 12 months
The primary outcome measure of this study is to estimate, after 12-months from the procedure, the percentage of patients with documented arrhythmia recurrences, recognized with the registration of at least 30 seconds of the same arrhythmias with 24h Holter ECG
次要结局
- Baseline patient's characteristic (clinical history and drug therapy) for subjects undergoing catheter ablation(within 30 minutes after ablation procedure)
- Primary arrhythmia recurrences and association with the baseline patient's characteristics (clinical history and drug therapy)(36 months)
- Estimate costs related to the use of health care resources(60 months)
- Rate of new onset of different arrhythmias (from the primary one)(12 months)
- Rate of the adverse events associated with the primary ablation procedure(12 months)
- Overall procedure time(Intraoperative)
- The percentage of acute procedural success of arrhythmias ablation(within 30 minutes after ablation procedure)
研究者
Giampiero Maglia
Head of Electrophysiology and Cardiac Pacing
Azienda Ospedaliera Pugliese Ciaccio