HD Mapping Observational Study - Asia Pacific
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 15
- 主要终点
- Number of Participants With Acute Success of RF Ablation After Electroanatomical Mapping With HD Mapping Catheters.
研究概览
简要总结
The aim of this study is to quantify and characterize the outcomes of radiofrequency (RF) ablation after, and the utility of, electroanatomical mapping with the market-released HD mapping catheters Inquiry™ AFocusII™ Double Loop and Advisor™ HD Grid, Sensor Enabled™ with the EnSite Cardiac Mapping System and the EnSite Automap module in subjects with AF in the real-world environment of the Asian population.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must provide written informed consent for study participation and willing and able to comply with the protocol described evaluations and follow up schedule
- •Subject must be over 18 years of age. (In Japan, the subject must be of 20 years of age or older)
- •Subject is diagnosed with AF as defined by:
- •Documented symptomatic paroxysmal AF defined as AF that terminates spontaneously or with intervention within 7 days of onset
- •Documented symptomatic persistent AF defined as continuous atrial fibrillation that is sustained beyond 7 days but less than 12 months
- •Subject is indicated for cardiac electroanatomical mapping and RF ablation procedure to treat AF
- •Subject is planned to have electroanatomical mapping performed with the HD mapping catheters under investigation
排除标准
- •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
Number of Participants With Acute Success of RF Ablation After Electroanatomical Mapping With HD Mapping Catheters.
时间窗: End of Procedure
The rate of acute success was defined as the proportion of subjects who receive HD mapping and RF energy delivery resulting in acute termination of clinical arrhythmia, defined by termination to SR (or AT if being treated for PersAF) or non-inducibility of clinical arrhythmia after ablation (cardioversion allowed prior to inducibility attempt). This measure is presented here as the number of participants with acute success, and the associated percentage of subjects (proportion \* 100%) with acute success is also displayed as the result of an automatic calculation.
Number of Participants With AAD-Free Long-Term Success
时间窗: 12-month post-procedure
Freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and off all class I/III AADs. This measure is presented here as the number of participants, and the associated percentage of subjects (proportion \* 100%) is also displayed as the result of an automatic calculation.
Number of Participants With Clinical Long-Term Success
时间窗: 12 months post-procedure
Freedom from all atrial arrhythmias (AF/AFL/AT) greater than 30 seconds (as documented by 24-hr Holter at 12-month follow-up) and on or off class I/III AADs. This measure is presented here as the number of participants, and the associated percentage of subjects (proportion \* 100%) is also displayed as the result of an automatic calculation.
次要结局
- Fluoroscopy Time(During Procedure)
- Overall Procedure Time(During Procedure)
- Substrate Characteristics Identified(During Procedure)
- Radiofrequency (RF) Time(During Procedure)
- Number of Used Mapping Points Per Minute(During Procedure)
- Mapping Time Associated With Mapping Arrhythmia(During Procedure)
- Number of Mapping Points Collected(During Procedure)
- Number of Mapping Points Used(During Procedure)
- Ablation Strategy(s) Used(During Procedure)