NCT00111488终止3 期
Randomized Study of Surgical Ablation With Microwave Energy for the Treatment of Atrial Fibrillation
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 200
- 试验地点
- 41
- 主要终点
- Freedom from atrial fibrillation at six months
研究概览
简要总结
The purpose of the Randomized Study of Surgical Ablation with Microwave Energy for the Treatment of Atrial Fibrillation (RESOLVE-AF) trial is to determine the safety and effectiveness of the Guidant FLEX® Microwave Surgical Ablation System in the treatment of permanent atrial fibrillation (AF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single
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
- •Patient age >= 18 years
- •Documented permanent AF (for at least three months)
- •Scheduled for an open chest cardiac surgery for the primary indication of mitral valve repair or replacement
- •Has been informed of the nature of the study, agrees to its provisions, and provided written informed consent, which was approved by the appropriate Institutional Review Board/Ethics Committee of the respective clinical site
排除标准
- •Cerebral vascular accident (CVA, stroke) or transient ischemic attack (TIA) within the previous 6 months
- •Myocardial infarction within the previous 6 weeks
- •Documented history of pulmonary vein stenosis
- •Previous ablation attempt for AF
- •Previous thoracic procedures
- •Left atrial size > 7.0 cm
- •Left ventricular ejection fraction < 30%
- •Presence of left atrial or left atrial appendage thrombi
- •Esophageal fistula or other stricture, untreated esophagitis, varices, dysphagia or odynophagia contraindicating transesophageal echocardiography
- •Known allergy or contraindication to warfarin therapy
- •Known allergy or contraindication to antiarrhythmic (Classes IA, IC, III) therapy
- •Other comorbidity with reduced life expectancy of less than 1 year or protocol noncompliance that would limit follow-up
- •Geographically remote or unable to return for follow-up examinations
- •Pregnant or planning to become pregnant during the study
- •Enrolled in any concurrent study, without Guidant written approval, that may confound the results of the study
结局指标
主要结局
Freedom from atrial fibrillation at six months
Composite major adverse event at one month
时间窗: One month
次要结局
- Change in Quality of Life at six months(6 months)
- Restoration of normal sinus rhythm at discharge(Hospital discharge)
- Composite Majour Adverse Events at three and 6 months(3 months and 6 months)
- Change in cardiac function at six month(6 month)
研究者
研究点 (41)
Loading locations...
相似试验
招募中
不适用
Microwave Ablation Versus Liver Resection For Early Hepatocellular Carcinoma in Patients With Borderline Liver FunctionCarcinoma, HepatocellularNCT03766555Chinese University of Hong Kong76
尚未招募
2 期
A Study of Microwave Ablation Combined With Immunotherapy ± Anti-angiogenic Drugs in the Treatment of Solid TumorsSolid TumorNCT06537505Beidahuang Industry Group General Hospital60
已完成
1 期
Preliminary Study of Microwave Tumoral Ablation Performances for the Treatment of Pulmonary, Renal and Bone Neoplasia.Bone TumorRenal TumorLung TumorNCT02862288Centre Hospitalier Universitaire de Besancon30
Unknown
不适用
Efficacy and Safety of Microwave Ablation in BosniakⅠ~ⅡF Cystic Renal LesionsKidney Diseases,CysticNCT03068195RenJi Hospital300
已完成
不适用
Comparison of Response and Recurrence Rates Following Percutaneous Microwave Coagulation Therapy Versus Percutaneous Radiofrequency AblationThermoablationChronic Liver DiseaseHepatocellular CarcinomaNCT02859753Centre Hospitalier Universitaire Dijon35