Atrial Fibrillation Ablation Pilot Study- Study Number AFI-20
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 5
- 主要终点
- The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months.
研究概览
简要总结
This is a prospective, non-randomized, multicenter, multi-country pilot study to evaluate the safety and effectiveness of the Ablation Frontiers Cardiac Ablation System for the ablative treatment of symptomatic permanent atrial fibrillation.
详细描述
The study shall be conducted according to ISO 14155. Results of this research study will be used to assess the performance and safety of the System and its components. Data may be combined with similar research at additional sites to create a greater understanding of the endpoints. Up to sixty (60) patients (including "roll-in" or training patients) will be enrolled in a non-randomized study to assess the safety and efficacy of the Ablation Frontiers Cardiac Ablation System. Further studies may be performed to gather additional data regarding the safety and efficacy of the system.
Patients with a history of symptomatic permanent AF, willing and able to sign an informed consent, and meeting all inclusion/exclusion criteria, as identified by the clinical investigator, will be enrolled in the study. Comparative and descriptive statistics will be used to summarize patient outcomes for the specified study endpoints.
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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of symptomatic permanent atrial fibrillation
- •Age between 18 and 70
- •Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
排除标准
- •Structural heart disease of clinical significance
- •Any prior ablation for atrial fibrillation
- •Prior ablation for arrhythmias other than AF within the past three months
- •Enrollment in any other ongoing arrhythmia study protocol
- •Any ventricular tachyarrhythmias currently being treated where the arrhythmia or the management may interfere with this study
- •Active infection or sepsis
- •Any history of cerebral vascular disease including stroke or TIAs
- •Pregnancy or lactation
- •Left atrial thrombus at the time of ablation
- •Untreatable allergy to contrast media
- •Any diagnosis of AF secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes
- •History of blood clotting (bleeding or thrombotic) abnormalities
- •Known sensitivities to heparin or warfarin
- •Severe COPD (identified by an FEV1 < 1)
- •Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectance, etc.)
研究组 & 干预措施
1
Ablation Management
干预措施: Ablation procedure and/or cardioversion (Procedure)
结局指标
主要结局
The acute/chronic safety endpoint is recording of all Severe Adverse Events (device and procedure related) followed for six months.
时间窗: 6 months
次要结局
- Effectiveness(6 months)