NCT05426759已完成不适用
Atrial Deganglionation as a Therapy for Cardiac Surgery Patients With Atrial Fibrillation
Atrian Medical Ltd.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2022年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- The Number of Patients in Sinus Rhythm at 12 Months.
研究概览
简要总结
A prospective single-arm study of ganglionated plexi ablation in cardiothoracic surgery patients with a history of atrial fibrillation.
详细描述
This study assesses the use of electroporation/pulsed field ablation (PFA) to selectively ablate ganglionated plexi in cardiothoracic surgery patients with atrial fibrillation. The PFA treatment will be performed in up to 12 patients with a history of paroxysmal atrial fibrillation. The primary end point will be recurrence of atrial fibrillation out to 1 year follow-ups.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age is between 18 and 70 years.
- •Scheduled for open-chest cardiothoracic surgery, for coronary artery bypass grafting and/or aortic valve repair/replacement
- •Have a documented medical history of paroxysmal or early-stage persistent atrial fibrillation within the previous 12 months.
- •Legally competent and willing to sign the informed consent.
- •Life expectancy of at least 2 years.
排除标准
- •Previous cardiac surgery
- •Prior pericardial interventions
- •Prior endocardial or epicardial pulmonary vein isolation (PVI), or any other invasive AF therapy
- •Previous or existing pericarditis
- •Use of amiodarone within the previous 12 months.
- •Long-standing persistent atrial fibrillation
- •Indication for mitral or tricuspid valve surgery
- •Indication for concomitant left atrial appendage (LAA) ligation or excision
- •History of previous radiation therapy on the thorax
- •History of previous thoracotomy.
- •Prior electrical or mechanical isolation of the Left Atrial Appendage (LAA)
- •The presence of LAA occlusion devices, coronary stents, prosthetic heart valves, pacemakers or implantable cardioverter defibrillators (ICDs)
- •Myocardial infarction within the previous 2 months
- •New York Heart Association (NYHA) Class IV heart failure symptoms
- •Left Ventricular Ejection Fraction (LVEF) < 40%, measured by transthoracic echocardiography (TTE)
- •Left atrial diameter > 5.0 cm, measured by transthoracic echocardiography (TTE)
- •The presence of left atrial thrombus when examined by transesophageal echocardiography (TEE)
- •The presence of atrial fibrillation (AF) attributable to non-cardiovascular causes such as thyroid disease, electrolyte imbalance/dehydration or other reversible causes
- •Active infection or sepsis as evidenced by increased white blood cell count, elevated C-reactive protein (CRP) or temperature > 38.5°C
- •Known or documented carotid stenosis > 80%
- •Stroke or transient ischemic attack within the previous 6 months
- •Known or documented epilepsy
- •Pregnancy or child-bearing potential without adequate contraception
- •Circumstances that prevent follow-ups
- •Drug abuse
- •Patients cannot be enrolled in another clinical study
结局指标
主要结局
The Number of Patients in Sinus Rhythm at 12 Months.
时间窗: 12 month
Patients will be monitored with 24 hour Holter at 12 months
次要结局
- Extension of AERP(Day 0)
研究者
研究点 (1)
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