Catheter Ablation vs. Medical Therapy in Congested Hearts With AF (CATCH-AF in Patients With Impaired LV Function): An Early Ablation Strategy Study Impact on Health Care Utilization
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 6
- 主要终点
- First Hospitalization for Heart Failure, Recurrence of AF or Direct Current Cardioversion
研究概览
简要总结
This study is a multi-center, randomized, unblinded, clinical trial. The objective is to determine if catheter-based atrial fibrillation (AF) ablation is superior to medical treatment in patients with impaired left ventricular (LV) function who have been diagnosed with symptomatic AF within the past 12 months.
详细描述
The purpose of the trial is to compare two different approved treatments for recently diagnosed AF: anti-arrhythmic medications and AF ablation. The study will be conducted to determine if one treatment is more effective than the other for patients with AF and heart failure. About 220 subjects with newly diagnosed AF from hospitals in the United States will take part in this study. Subjects will be randomized in a 1:1 fashion to either AF catheter ablation or anti-arrhythmic medication for treatment of AF. Both therapies are considered Standard of Care.
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
- •must be 18 years of age or older
- •Provide signed written Informed Consent
- •symptomatic AF documented by EKG or heart rhythm monitoring within 12 months
- •patients should be on optimal medical therapy for heart failure for 3 months prior to randomization. Adjustments to medications within this 3 month period are permitted.
- •chronically impaired LV function defined as EF between 20%-45% within last 3 months
- •all patients should be on an optimal therapy for impaired LV function
- •ability to complete 6 minute walk test
- •eligible for catheter ablation and anti-arrhythmic drugs
排除标准
- •women of childbearing potential unless post- menopausal or surgically sterile
- •patients hospitalized for heart failure within the 3 months prior to randomization
- •reversible causes of AF such as pericarditis, thyroid disorders, acute alcohol intoxication, recent major surgical procedures or trauma
- •recent reversible LV impairment that may be attributed to AF with rapid ventricular response and may improve with introduction of rate control
- •valvular heart disease requiring surgical intervention
- •Coronary Artery Disease (CAD) requiring surgical or percutaneous intervention
- •early post-operative AF (within 3 months of surgery)
- •previous MAZE or left atrial instrumentation (including ablation and left atrial appendage exclusion)
- •history of Atrioventricular Node (AVN) ablation
- •hypertrophic cardiomyopathy
- •prolonged QT interval
- •liver failure
- •renal failure requiring dialysis
- •social factors that would preclude follow up or make compliance difficult- history of drug, alcohol or substance abuse
- •contraindications to the use of AADs and/or anticoagulation therapy
- •Currently enrolled in, or discontinued within the last 30 days from a clinical trial involving an investigational product or non-approved use of a drug or device or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
- •severe pulmonary disease
- •documented intra-atrial thrombus, tumor, or structural abnormality which precludes catheter introduction
- •unwilling to comply with protocol requirements or deemed by the investigator to be unfit for the study.
研究组 & 干预措施
AF catheter Ablation
Pulmonary Vein Isolation catheter ablation for treatment of AF. AF catheter ablation is an FDA approved treatment for AF
干预措施: Catheter Ablation (Device)
FDA approved anti arrhythmic drug
FDA approved anti arrhythmic drug for the treatment of AF will be based on treating physicians' preference in accordance to guidelines.
干预措施: FDA approved anti arrhythmic drug (Drug)
结局指标
主要结局
First Hospitalization for Heart Failure, Recurrence of AF or Direct Current Cardioversion
时间窗: 12 months
Time measured in days to first hospitalization for heart failure, recurrence of AF or Direct Current cardioversion after the treatment period (first 3 months post enrollment or post procedure during which repeat ablation can be performed and titration of AADs can be performed).
次要结局
- Distance Walked in a 6-mile Walk Test(3 months through 15 months)
- Change in the Rand 36-Item Health Survey(3 months through 15 months)
- Change in Ejection Fraction (EF)(baseline through15 months)
- Total Number of Cardiovascular Hospitalization(15 months)
- Time to Recurrence if AF Lasting Longer Than 30 Seconds(15 months)