ACTRN12619000509167已完成未知
Assessment of Safety and Performance of the Radio Frequency Catheter System to Isolate Pulmonary Veins in the Treatment of Paroxysmal Atrial Fibrillation Control Study
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
There were no specified safety or effectiveness endpoints for this study. As the sample-size was not powered, limited conclusions can be drawn from the dataset.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •History of symptomatic, documented paroxysmal atrial fibrillation
- •Suitable candidate for catheter non-emergent intra-cardiac mapping and ablation
排除标准
- •Structural heart disease of clinical significance including previous cardiac surgery (excluding CABG or mitral valve repair)
- •Documented EF <30%
- •Left atrial diameter of >55mm
- •Contraindication to anticoagulation therapy
- •Unstable angina or ongoing myocardial ischemia
- •Myocardial infarction within 3 months of enrollment
- •Congenital heart disease where the underlying abnormality increases the risk of the ablation
- •Prior Atrial Septal Defect or Patent Foramen Ovale Closure with a device using a transcatheter percutaneous approach
- •Hypertrophic cardiomyopathy (LV septal wall thickness >1.5cm)
- •Pulmonary hypertension (>50mm Hg)
- •Prior ablation for atrial fibrillation
- •Enrollment in any other ongoing arrhythmia study protocol
- •Patients with severely impaired kidney function as measured by Cockcroft-Gault Glomerular Filtration Rate (GFR) 3 with a GFR < 29
- •Active gastrointestinal bleeding, infection or fever (>100.5/38C) or sepsis
- •Short life expectancy (<1 year) due to illness such as cancer, pulmonary,hepatic or renal disease
- •Significant anemia (hemoglobin < 8.0 / dl)
- •Severe uncontrolled systemic hypertension with systolic >200mm Hg within ast 30 days
- •Documented anaphylaxis during previous exposure to contrast media
- •Bleeding or clotting disorders or thrombotic disorder under treatment
- •Uncontrolled diabetes
- •Women who are pregnant and not willing to use contraception for the duration of the study
- •Severe COPD (identified by an FEV1 <1)
- •Unwilling or unable to comply with any protocol or follow up requirements
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