Hybrid Ablation Plus Medical Therapy for Persistent Atrial Fibrillation (HYBRID AF)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- Atrial Fibrillation (AF) Burden Defined as the Mean Amount of Time Spent in AF Over a Pre-specified Period of Time (Excluding Short AF Episodes of ≤30 Seconds) by the Biotronik ICM (BioMonitor3® or Future Generation of Biotronik ICM).
研究概览
简要总结
This clinical trial is designed to compare two management strategies for the treatment of asymptomatic/subclinical atrial fibrillation after ablation based on data from the Biotronik ICM (BioMonitor3® or future generation of Biotronik ICM).
详细描述
In this study, subjects will be randomized (1:1) to conventional AF management vs. Biotronik ICM-guided AF management following ablation for persistent AF. Subjects will be followed for 15 months including a 3 month blanking period following AF ablation. The study subject population will include subjects with persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than 1 year), according to current guideline indications for persistent AF ablation and ICM (Biotronik ICM) implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •18 years of age or older
- •History of persistent atrial fibrillation (sustained AF episode lasting more than 7 days, but less than a year)
- •Planned to undergo first AF ablation with successful Biotronik ICM implant before or at time of ablation
排除标准
- •Paroxysmal atrial fibrillation
- •Long persistent atrial fibrillation (continuous atrial fibrillation that lasts more than 1 year)
- •Permanent atrial fibrillation
- •Left atrial diameter of 60 mm or greater
- •Patients with CHF status prohibiting EP study and ablation, but may be re-considered for enrollment later after effective treatment
- •Patients with metabolic derangements (e.g. renal/hepatic failure, electrolyte disturbance, etc.), prohibiting EP study and ablation or antiarrhythmic medical therapy (e.g. dofetilide, sotalol or amiodarone, etc.)
- •Patients with an intra-cardiac thrombus, but may be re-considered for enrollment later after effective treatment
- •Serious known concomitant disease with a life expectancy of < 1 year
- •Pregnancy or nursing
- •Unwilling or unable to give informed consent
- •Existing CIED such as pacemaker or ICD
结局指标
主要结局
Atrial Fibrillation (AF) Burden Defined as the Mean Amount of Time Spent in AF Over a Pre-specified Period of Time (Excluding Short AF Episodes of ≤30 Seconds) by the Biotronik ICM (BioMonitor3® or Future Generation of Biotronik ICM).
时间窗: Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period)
In the present study AF burden will be assessed at 3-month intervals during the 12 months following the blanking period (3-months post-ablation), and the difference at the end of the follow-up period of one year will serve as the primary comparison outcome between the two treatment groups.
次要结局
- Number of Participants With Symptomatic AF Recurrence (Regardless of Duration).(Between enrollment and 15 months.)
- Number of Participants With Cardiac Hospitalization.(Between enrollment and 15 months.)
- Number of Participants With Clinically Significant (>30 Min) Atrial Arrhythmia (Atrial Fibrillation, Atrial Flutter or Atrial Tachycardia) as Detected and Documented by Biotronik ICM After the Performance of the Index AF Ablation Procedure.(Between enrollment and 15 months (excluding the initial 3-month blanking period) (assessed in a recurrent event analysis).)
- Number of Participants With Repeat AF Ablation.(Between enrollment and 15 months.)
- Number of Deaths.(Between enrollment and 15 months.)
- Number of Participants With Incidence of Repeat Procedures.(Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period))
- Number of Participants With Healthcare Utilization, Defined as Hospitalization for Any Cause, ED Visits, and Unplanned Office Visits.(Between enrollment and 15 months.)
- Number of Participants With Atrial Flutter or Tachycardia.(Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period))
- Number of Participants With Major Adverse Events Requiring Rehospitalization During Follow-up.(Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period))
- Quality of Life as Assessed by the Atrial Fibrillation Effect on QualiTy-of-life (AFEQT) Questionnaire(Between months 3 and 15 after the ablation procedure (to exclude the first 3 month blanking period))
研究者
David Huang
Professor Medicine M&D-Cardiology Div
University of Rochester