NCT02991313已完成不适用
Evaluation of a Multi-electrode Linear Type Catheter (D-1368-01-SI) for Endocardial Ablation of Patients With Persistent Atrial Fibrillation (LME-167)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Confirmation of bi-directional block
研究概览
简要总结
The purpose of this trial is to assess acute safety and performance of the Multi-electrode Linear Type Catheter in conjunction with generator software V2.4.0 or above when used for the treatment of Persistent Atrial Fibrillation.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Signed the Patient Informed Consent Form (ICF)
- •Documented ongoing or previous symptomatic persistent AF (by physician's note indicating continuous AF ≥ 7 days)
- •Failed at least one antiarrhythmic drug (AAD) (class I or III) as evidenced by recurrent symptomatic AF, or intolerable to the AAD.
- •Able and willing to comply with all pre-, post-, and follow-up testing and requirements.
排除标准
- •Previous surgical or catheter ablation for atrial fibrillation
- •Current condition of continuous AF > 12 months (1 year) (Longstanding Persistent AF) or previously diagnosed as having Longstanding Persistent AF
- •Any carotid stenting or endarterectomy
- •Known with Cardioversion refractory history (the inability to restore sinus rhythm for 30 secs or longer following electrical cardioversion.
- •LA size > 55 mm
- •AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •Significant pulmonary disease (i.e. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms
- •Uncontrolled heart failure or NYHA function class III and IV
- •MI within the past 2 months
- •Any cardiac surgery (i.e. CABG) within the past 2 months
- •Subjects that have ever undergone valvular cardiac surgical/ percutaneous procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)
- •Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
- •Documented thromboembolic event (including TIA) within the past 12 months
- •Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study
- •Active illness or active systemic infection or sepsis
- •Unstable angina
- •History of blood clotting or bleeding abnormalities
- •Contraindication to anticoagulation (eg, heparin or warfarin)
- •Life expectancy less than 12 months
- •Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation
- •Presence of a condition that precludes vascular access
- •Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation
- •Currently enrolled in another device, biologics, or drug study
- •Contraindication for use of the investigational devices , as indicated in the respective Instructions For Use
结局指标
主要结局
Confirmation of bi-directional block
时间窗: Intraoperative
Acute procedural success defined as: Confirmation of bi-directional block in all linear lesions
Early Onset of Primary Adverse Events
时间窗: Within 7 days
Incidence of early onset (within 7 days of ablation procedure) primary Adverse Events
Confirmation of entrance block
时间窗: Intraoperative
Acute procedural success defined as: Confirmation of entrance block in all targeted PVs after adenosine and /or isoproterenol challenge (taking into account a 30 minute waiting period from the last RF application at a PV target before verification)
次要结局
- Incidence of Serious Adverse Device Effects (SADEs)(1 Year)
- Freedom from documented Atrial Fibrillation/Atrial Flutter/Atrial Tachycardia(3, 6 and 12 months post-procedure)
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