NCT03032965已完成2 期
Adenosine Study in Paroxysmal Atrial Fibrillation
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Freedom From Any Atrial Arrhythmias
研究概览
简要总结
The purpose of this study is to determine if additional ablation during the first procedure as the result of the ability to medically induce quiet atrial arrhythmias will improve clinical outcome in patients with atrial fibrillation thus decreasing the need for additional ablation procedures.
详细描述
Hypothesis
- Adenosine reveals incomplete conduction block due to partial tissue injury/stunning during catheter ablation of atrial fibrillation.
- Identification of incomplete conduction block by adenosine improves clinical outcomes including an increase in efficacy and a decrease in need for repeat procedures after catheter ablation of atrial fibrillation.
Objectives:
- In patients with paroxysmal Atrial Fibrillation (AF), the prevalence of Pulmonary Vein (PV) reconnection during adenosine infusion after complete PV isolation using conventional techniques will be determined.
- Patients will be randomized to further ablation to achieve complete isolation during adenosine infusion vs to no further ablation.
- Primary endpoint of the study will be freedom from any atrial arrhythmias 6 months after a single ablation procedure in the absence of antiarrhythmic drug therapy.
- Secondary endpoints will include number of repeat ablation procedures because of documented recurrence of symptomatic AF or atrial flutter/tachycardia, outcome after 2 ablation procedures; Proportion of patients with AF or atrial flutter/tachycardia occuring during the first three months post ablation, prevalence of recovery of conduction into PVs during repeat ablation procedures in both groups, procedure duration, and incidence of peri-procedural complications including stroke, PV stenosis, cardiac perforation, atrio-esophageal fistulae, and death.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >18 and <75 who are able to give informed consent undergoing atrial fibrillation ablation procedure.
- •Paroxysmal Atrial fibrillation lasting = 7 days which is self-terminating. It is considered recurrent if two or more episodes occur.
- •Failure or unwilling to take class I or III anti-arrhythmic drugs
排除标准
- •History of asthma
- •Patients with severe coronary artery disease, stable/unstable angina, or ongoing myocardial ischemia
- •Previous cardiac surgery ( excluding CABG and mitral valve surgery)
- •Symptomatic congestive heart failure including but not limited to NYHA III/IV and/or documented ejection fraction <40% measured by acceptable cardiac testing,
- •Left atrial diameter >55mm
- •Moderate to severe mitral or aortic valve disease
- •Myocardial infarction within three months of enrollment
- •Congenital heart disease where it increases the risk of an ablative procedure
- •Prior ASD/PFO closure with a device using a percutaneous approach
- •Hypertrophic cardiomyopathy (LV wall thickness >1.5mm)
- •Pulmonary Hypertension (mean or systolic PA pressure> 50mmHg on Doppler echocardiography
- •Any prior ablation of atrial fibrillation
- •Enrollment in any other arrhythmia protocol
- •Any ventricular arrhythmia being treated where the arrhythmia or management may interfere with this study
- •Active infection or sepsis
- •Any history of cerebrovascular disease including stroke or TIAs
- •Pregnancy or lactation
- •Left atrial thrombus at the time of ablation
- •Untreatable allergy to contrast media
- •Any diagnosis of atrial fibrillation secondary to electrolyte disturbance, thyroid disease, or any other reversible or non-cardiovascular causes
- •History of blood clotting(bleeding or thrombotic) abnormalities
- •Known sensitivities to heparin or warfarin
- •Severe COPD (defined as FEV1 <1)
- •Severe comorbidity or poor general physical/mental health that, in opinion of the investigator, will not allow the patient to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy)
研究组 & 干预措施
Adenosine and Isoproterenol
Experimental
Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.
干预措施: Adenosine (Drug)
Adenosine and Isoproterenol
Experimental
Patients in this group will receive 12-24mg of adenosine for each PV in order to assess dormant PV conduction.
干预措施: Isoproterenol (Drug)
Isoproterenol
Other
This group will not receive adenosine during the procedure.
干预措施: Isoproterenol (Drug)
结局指标
主要结局
Freedom From Any Atrial Arrhythmias
时间窗: 2- 14 months after Ablation procedure
Primary endpoint of the study will be number of participants who are free from any atrial arrhythmias after a single ablation procedure in the absence of antiarrhythmic drug therapy
次要结局
- Number of Subjects Who Need Repeat Ablations(date of ablation to 6 months after procedure)
- Number of Pulmonary Veins That Recovered Conduction During Repeat Ablation Procedures in Both Groups(post-procedure (6 months))
- Incidence of Pulmonary Vein Stenosis(6 months post-procedure)
- Incidence of Atrio-esophageal Fistula(within 4 weeks)
- Incidence of Stroke(peri-procedural (0 to 30 days after procedure))
- Incidence of Death(with 90 days of the procedure)
- Number of Subjects With AF or Atrial Flutter/Tachycardia Occurring During the First Three Months Post Ablation(first three months post ablation)
- Incidence of Cardiac Perforation(within 24 hours)
研究者
Hamid Ghanbari
Assistant Professor of Internal Medicine
University of Michigan
研究点 (1)
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