Linac Based STereotactic Arrhythmia Radioablation (STAR) of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events related to STAR treatment
研究概览
简要总结
Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia. Current European guidelines recommend catheter ablation of AF in symptomatic patients refractory to antiarrhythmic therapy. Pulmonary vein isolation (PVI) remains the cornerstone of any ablation procedure irrespective of patient characteristics. Recently, stereotactic arrhythmia radioablation (STAR) with precise high-dose of radiation was used to treat ventricular arrhythmias in patients with a high risk of complications during transcatheter ablation.
详细描述
Exploratory study to investigate the feasibility of STAR for the treatment of paroxysmal AF in elderly patients in which a rhythm control strategy is indicated. Patients will be followed-up for 12 months after STAR treatment for a safety assessment and AF recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 70 years
- •Symptomatic Paroxysmal AF
- •Antiarrhythmic drugs intolerance or non-response to antiarrhythmic drugs
- •Understands the nature of the study, treatment procedure and provides written informed consent
- •Willing to comply with specified pre-, post- and follow-up testing, evaluations and requirements
- •Expected to remain available for at least 24 months after enrollment
排除标准
- •Permanent AF
- •Need or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial
- •Unstable angina
- •Presence of any disease that is likely to shorten life expectancy to < 1 year
- •Any cardiac surgery within three months prior to enrolment
- •Awaiting cardiac transplantation or other cardiac surgery within the next year
- •Myocardial infarction (MI) within 60 days prior to enrolment
- •Contraindications to oral anticoagulation
- •Active systemic infection or sepsis
- •Left atrial thrombus (e.g., transesophageal echocardiogram (TEE), CT and ICE)
- •History of a documented thromboembolic event such as stroke or transient ischemic neurological attack (TIA) in the three months prior to enrollment.
- •Currently enrolled in another trial that has not completed the required follow-up period and would conflict with this study.
- •Any other clinical condition that might jeopardize patient safety during participation in this trial or prevent the subject from adhering to the trialprotocol
研究组 & 干预措施
STAR Treatment
Patients performing STAR treatment
干预措施: STAR Treatment (Radiation)
结局指标
主要结局
Incidence of Adverse Events related to STAR treatment
时间窗: Baseline through 12-months
To estimate the cumulative proportion of patients' Adverse Events related to STAR treatment
次要结局
- Incidence of AF recurrence(Baseline through 12-months)
- Long-term clinical outcomes(Baseline through 10-years)
研究者
Massimo Grimaldi
Head of Arrhythmology and Electrophysiology Unit
Miulli General Hospital