NCT04652778Unknown不适用
Safety & Performance of Ablation With the Centauri System for the Elimination of Atrial Fibrillation (SPACE AF)
Galaxy Medical, Inc.2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2021年9月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Acute Procedural Success
研究概览
简要总结
This is a prospective, single-arm, open-label clinical study following patients to 1 year, to evaluate the safety and performance of the Centauri system for catheter ablation of atrial fibrillation (AF). The study will include adult patients (age 18-75 years) who are indicated for a first-time catheter ablation of AF where the pre-procedure treatment plan contemplates pulmonary vein isolation (PVI) in patients with paroxysmal AF (PAF), and PVI - with or without additional left atrial ablations - in patients with Persistent AF (PeAF) of short duration (< 1 year).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Failure of at least one antiarrhythmic drug (AAD) (Class I - IV) for AF, as evidenced by recurrent symptomatic AF or intolerable side effects due to AAD
- •Diagnosis of recurrent symptomatic paroxysmal AF (PAF) or short duration (< 1 year) Persistent AF (PeAF) with the following documentation:
- •a. PAF i. Physician's note indicating symptoms consistent with recurrent symptomatic PAF AND ii. ≥ 2 episodes of PAF within 12 months prior to enrollment. At least one episode should be documented by ECG, transtelephonic monitor (TTM), Holter monitor, telemetry strip or similar, showing at least 30 seconds of AF b. PeAF i. Physician's note indicating symptoms consistent with continuous AF episode lasting longer than 7 days but less than 1 year AND ii. Any 24-hour continuous ECG recording documenting persistent AF within 6 months prior to enrollment OR iii. Two ECGs from any form of rhythm monitoring showing continuous AF taken at least 7 days apart within 12 months prior to enrollment OR iv. History of direct current cardioversion (DCCV) performed within 12 months prior to enrollment
- •Age 18 through 75 years-old on the day of enrollment
- •Patient is indicated for an ablation procedure according to society guidelines or investigational site practice
- •Patient is willing and able to give informed consent.
- •Patient is willing, able, and committed to participate in baseline and follow-up evaluations for the full duration of the study.
排除标准
- •Long-standing persistent AF (continuous AF sustained > 1 year)
- •AF secondary to electrolyte imbalance, thyroid disease, alcohol abuse, or other reversible/non-cardiac causes
- •Left atrial anteroposterior diameter > 5.0 cm as documented by transthoracic echocardiography (TTE) or computed tomography (CT) within 6 months prior to enrollment
- •Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the index ablation procedure
- •Use of amiodarone within 6 weeks prior to enrollment
- •Prior left atrial ablation or surgical procedure (including left atrial appendage (LAA) device or occlusion)
- •Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
- •Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- •Presence of any pulmonary vein stents
- •Presence of any pre-existing pulmonary vein stenosis
- •Pre-existing hemidiaphragmatic paralysis
- •Atrial or ventricular septal defect closure
- •Atrial myxoma
- •Presence of any prosthetic heart valve
- •Hemodynamically significant valvular disease
- •History of pericarditis
- •History of Rheumatic heart disease
- •History of thromboembolic event within 6 months of time of enrollment or evidence of intracardiac thrombus at time of procedure
- •Any of the following events within 3 months of enrollment
- •Myocardial infarction (MI)
- •Unstable angina
- •Percutaneous coronary intervention
- •Heart surgery including coronary artery bypass grafting
- •Heart failure hospitalization
- •Cerebral ischemic event (stroke or transient ischemic attack (TIA))
结局指标
主要结局
Acute Procedural Success
时间窗: During treatment procedure
Proportion of patients with confirmed pulmonary vein isolation (PVI) during the index procedure
Chronic Success
时间窗: 12 months
Proportion of patients with freedom from AF recurrence after a single procedure
Device and Procedure related serious adverse event rate
时间窗: 30 days
The rate of system-related and procedure-related serious adverse events of interest
次要结局
未报告次要终点
研究者
研究点 (2)
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