High-Density (HD) Wave Mapping in Subjects With Atrial Fibrillation as a Predictor of Recurrence After a Single Ablation Procedure Using a PVI-Only Strategy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 30
- 主要终点
- Percentage of Subjects With One-year Success
研究概览
简要总结
The aim is to use the GRID to characterize the atrial substrate and develop a model for predicting recurrence rates after a single procedure using a PVI only approach and a contact catheter.
详细描述
This clinical investigation is intended to characterize the left atrial substrate using the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™ in an HD Wave configuration and correlate different factors with 12-month success after a single ablation procedure using a pulmonary vein isolation (PVI) approach without further substrate modification.
This is a post-market, single-arm, multi-center, prospective interventional study of the Advisor™ HD Grid Mapping Catheter, Sensor Enabled™. This study is aimed at determining correlations between pre-ablation mapping characteristics and outcomes after catheter ablation of atrial fibrillation.
Approximately 300 subjects at up to 20 sites worldwide will be enrolled.
Subjects will be followed until they complete their 12-month visit. Clinical Investigation visits will occur at Baseline (confirmation of eligibility), Index Procedure, 3 months, 6 months, and 12 months. Endpoints will be analyzed when all subjects have completed their 12-month follow up visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Documented atrial fibrillation with planned endocardial ablation procedure
- •Age 18 years or older
- •Able and willing to provide written informed consent prior to any clinical investigation related procedure
- •Able and willing to complete all required study procedures through 12 months
排除标准
- •Long-standing persistent atrial fibrillation defined as continuous AF greater than 12 months in duration
- •Previous ablation or surgery in the left atria
- •Implanted left atrial appendage occluder
- •Implanted mitral or tricuspid valve replacement
- •Implanted cardiac defibrillator (ICD)
- •Participation in another clinical investigation that may confound the results of this study
- •Pregnant or nursing
- •Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
- •Life expectancy less than 12 months
结局指标
主要结局
Percentage of Subjects With One-year Success
时间窗: the end of the 3-month blanking period to 12 months following a single ablation procedure
Defined as freedom from atrial fibrillation, atrial flutter and atrial tachycardia after removal from the antiarrhythmic drug therapy as assesses from the end of the 3-month blanking period to 12 months following a single ablation procedure. Kaplan-Meier survival analysis will be conducted to analyze time-to-event variables.
次要结局
未报告次要终点