Monitoring Safety and Recurrence of Paroxysmal Atrial Fibrillation After 1st Cryo-balloon Ablation with and Without Antiarrhythmic Drug Therapy During the 90-day Blanking Period - Examined with Adverse Event Monitoring and Cardiovascular Implantable Electronic Devices (CIEDs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Symptom Assessments
研究概览
简要总结
This study is being done to find out if patients taking Anti Arrhythmia Drugs (AADs) after cryoballoon ablation for atrial fibrillation, compared to patients who do not take Anti- Arrhythmic Drugs after an ablation affect Atrial Fibrillation from coming back. The study will also look at the side effects of the AADs.
详细描述
Pulmonary vein isolation (PVI) is a cornerstone ablation strategy used in the management of paroxysmal atrial fibrillation (PAF), and it is a class IA indication for anti-arrhythmic drug (AAD) refractory symptomatic PAF. However, the consensus statements are vague about the utility of AAD management during the 90-day blanking window post-PVI. Moreover, there is no specific guidance to cryoballoon users on the usage of AADs during the 90-day blanking period that exists anywhere in the published literature. Simply, these studies have not been conducted with the cryoballoon procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Drug refractory and recurrent Paroxysmal Atrial Fibrillation
- •The subject meets medical criteria for cryoballoon ablation to treat Paroxysmal AF
- •Age 18 to 80 years
- •The subject has a Cardiovascular Implantable Electronic Device (CIED) that captures AF episodes, such as an implantable loop recorder, pacemaker, or implantable cardioverter defibrillator (ICD) with a properly functioning atrial lead.
排除标准
- •Use of any Anti- Arrhythmic Drugs for ventricular arrhythmias
- •Ejection Fraction (EF)<45%
- •Prior A. Fib. ablation
- •Pregnant women
结局指标
主要结局
Symptom Assessments
时间窗: 12 months
Symptom assessments by clinical follow up and phone calls, including symptom severity score using the Severity of Atrial Fibrillation Scale between the two groups.
Adverse Events Assessments
时间窗: 12 months
Ongoing assessment of adverse events in both arms of the study, including AADs side effects in 90-day blanking period.
Compare recurrence, recurrence rate, burden of atrial fibrillation post ablation between the two groups.
时间窗: 12 months
Rhythm status through implantable loop recorder (or pacemaker with functioning atrial lead) at 3 month, 6 month, 12 month compared between two treatment groups, including: A) AF burden (Average amount of time in AF per day) B) AF recurrence rate (Frequency of AF, occurrences per day) C) Time to AF recurrence
次要结局
- The cost of AADs during the 90-day blanking period.(12 months)
- Assess the rate of hospitalizations, emergency room visits, and unscheduled cardiology visits for the treatment of AF between the two groups(12 months)
- The differential usage of anticoagulation therapy between two arms.(12 months)