NCT00566176Unknown2 期
Thoracoscopically-Assisted Epicardial Bilateral Pulmonary Vein Isolations Using the AtriCure Bipolar System and Exclusion of the Left Atrial Appendage for the Treatment of Atrial Fibrillation
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 25
- 试验地点
- 10
- 主要终点
- The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach.
研究概览
简要总结
RESTORE SR II is a feasibility study on the minimally invasive use of the AtriCure Bipolar System for PV Isolation on a beating heart for the treatment of all types of atrial fibrillation in a sole therapy operation (not concomitant to another cardiac operation).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient between 18 and 80 years of age
- •Patient with symptomatic AF and failure or intolerance of one or more Class I or Class III AADs and:
- •Who describes 3 or more symptomatic AF episodes during the 6 month period prior to enrollment, with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment or,
- •Who has documented AF within the 6 months proceeding enrollment that did not terminate spontaneously (including patients in continuous AF) or,
- •Who is unwilling or unable to take anticoagulants, with 3 or more symptomatic episodes during the 6 month period prior to enrollment with at least 1 electrocardiographically documented episode of AF in the 4 months prior to enrollment.
- •Left Atrial Size < 6 cm (determined by echocardiography performed within 60 days of enrollment), unless the LV dysfunction is thought to result (at least in part) from AF
- •Left Ventricular Ejection Fraction ≥ 30% (determined by echocardiography performed within 60 days of enrollment)
- •Patient is willing and able to provide written informed consent.
- •Patient has a life expectancy of at least 2 years.
- •Patient is willing and able to attend the scheduled follow-up visits.
- •Weight < 325 lbs
排除标准
- •Prior cardiac catheter ablation for the treatment of arrhythmia within 4 months
- •Prior cardiac surgery
- •Patients requiring any open heart procedure (e.g. CABG, valve replacement or repair, atrial septal defect repair, etc.)
- •Class IV NYHA heart failure symptoms, unless these symptoms are considered to be due to uncontrolled AF
- •Cerebrovascular accident within previous 6 months
- •Known carotid artery stenosis greater than 80%
- •Evidence of significant active infection
- •Patient unable to undergo TEE
- •Pregnant woman
- •Requires anti-arrhythmic drug therapy for the treatment of ventricular arrhythmia
- •Presence of thrombus in the left atrium
- •Patient has co-morbid condition that in the opinion of the investigator poses undue risk of general anesthesia or port access cardiac surgery
- •Patient is enrolled in another investigational study
结局指标
主要结局
The primary outcome is the feasibility of performing this operation by demonstrating the ability to consistently isolate the right and left PVs using this minimally invasive approach.
时间窗: Perioperatively
The primary safety endpoint will be determined by assessing the rate of serious adverse events.
时间窗: Discharge/30 Days
次要结局
未报告次要终点
研究者
研究点 (10)
Loading locations...
相似试验
撤回
2 期
AtriCure Minimally Invasive Surgical Ablation for Atrial Fibrillation/RESTORE IIBAtrial FibrillationNCT00571779AtriCure, Inc.
已完成
不适用
Pivotal Study Of A Dual Epicardial & Endocardial Procedure (DEEP) ApproachPersistent or Longstanding Persistent Atrial FibrillationAtrial FibrillationNCT02393885AtriCure, Inc.90
终止
不适用
Investigational Device Exemption (IDE) Study for the Approval of Closed Loop Stimulation (CLS) and Cardiac Resyncronization Pacing Therapies (CRT) for the Treatment of Atrial Fibrillation (AF) With Ablate and PaceAtrial FibrillationCongestive Heart FailureNCT00356057Biotronik, Inc.153
已完成
不适用
AtaCor Subcostal Temporary Extravascular Pacing III StudyConduction DefectNCT04538287AtaCor Medical, Inc.33
进行中（未招募）
不适用
NHLBI DIR Transcatheter Mitral Cerclage Annuloplasty Early Feasibility StudyFunctional Mitral RegurgitationNCT03929913National Heart, Lung, and Blood Institute (NHLBI)19