Anti-Arrhythmic Medication (Amiodarone) Post Surgical Ablation for Atrial Fibrillation - Is it Necessary?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 186
- 试验地点
- 2
- 主要终点
- Change in Status of Rhythm Between Baseline and Follow-Up - Recurrence of Atrial Fibrillation
研究概览
简要总结
The purpose of this study is to determine whether anti arrhythmic medication, specifically Amiodarone, is required during the first three months post surgical ablation.
Hypothesis: Amiodarone will not be required during the first three months as verified by no increase in rehospitalizations for recurrent Atrial Fibrillation, and report of sinus rhythm at surgical follow up (approximately 3 weeks from date of surgery), 6 weeks and 12 weeks to include patients' first follow up with cardiologist at approximately 3 months post surgery.
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
- •Subject is ≥ 18 years of age
- •Subject must be diagnosed with Persistent and/or Longstanding Persistent Atrial fibrillation as classified by the HRS Guidelines 8 [0]
- •Subject must be selected as a candidate to undergo the Cox- Maze procedure for ablation of atrial fibrillation
- •The Cox Maze procedure may be done as a stand alone procedure or combined with other cardiac surgical procedures either via a median sternotomy or a right thoracotomy:
- •Subject has a Left Ventricular Ejection Fraction (LVEF) ≥ 30%
- •Subject would normally be prescribed Amiodarone as an anti arrhythmic medication post surgical ablation
- •Subject is able and willing to provide written informed consent and HIPAA authorization
- •Subject is able and willing to comply with all study requirements including attending all follow-up visits as deemed necessary by personal physician (cardiologist)
- •Subject has a life expectancy of at least one year
排除标准
- •Subject has undergone previous attempts at surgical Maze procedure or other AF operation, including surgical or catheter ablation Subject has an accessory pathways disorder (e.g. Wolff-Parkinson-White syndrome)
- •Subject is in Class IV NYHA
- •Subject has had a documented MI within 6 weeks prior to study enrollment
- •Subject needs emergent cardiac surgery (i.e. cardiogenic shock)
- •Subject has known carotid artery stenosis greater than 80%
- •Subject has a current diagnosis of active systemic infection
- •Subject is pregnant, planning to become pregnant within 12-14 months, or lactating
- •Subject requires preoperative intra-aortic balloon pump or intravenous inotropes
- •Subject has renal failure requiring dialysis
- •Subject is diagnosed with hepatic failure
- •Subject is on anti-arrhythmic drug therapy for the treatment of a ventricular arrhythmia
- •Subject has a known connective tissue disorder
- •Subject is incarcerated
- •Subject has previous or current therapy that could compromise tissue integrity including thoracic radiation, chemotherapy, long-term oral or injected steroids
- •Subject is an intravenous drug and/or alcohol abuser
- •Subject is participating in concomitant research studies of investigational products ( e.g. Appendage closure devices, atrial septal defect patches)
结局指标
主要结局
Change in Status of Rhythm Between Baseline and Follow-Up - Recurrence of Atrial Fibrillation
时间窗: 3, 6, 12 weeks and 6 months post-procedure
To demonstrate equality in clinically significant recurrence of AF following ablation while showing superiority for complication and side effect rates in those off Amiodarone vs. those on. •% recurrence AF by telemetry at 3 wks and 24-48 hr Holter monitoring at 6 and 12 wks post procedure, EKG at first visit between 6 and 12 wks post discharge and or ER visit for rapid heart rate in atrial arrhythmia requiring treatment; permanent pacemaker interrogation reports at first follow up visit. •Post-procedure major adverse event rate at 6 mos post-procedure related to side effects of Amiodarone.
次要结局
- Major Adverse Event Rate(30 days post-procedure)