Ablation Versus Medical Management of Atrial Fibrillation in Heart Failure With Preserved Ejection fRaction and the Effects on Exercise Capacity (AMPERE)
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Atrial Fibrillation
- 发起方
- Inova Health Care Services
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in AF burden as assessed by difference in percentage of time an individual is in AF
- 状态
- 进行中（未招募）
- 最后更新
- 3个月前
概览
简要总结
This is a prospective non-blinded randomized control pilot study comparing the effect of pulmonary vein isolation against medical management of atrial fibrillation in patients with Heart Failure with preserved Ejection Fraction (HFpEF).
详细描述
Recent studies using PVI for rhythm control in patients with heart failure with reduced ejection fraction (HFrEF) have shown improvement in systolic ejection fraction, exercise capacity, quality of life, and a significant reduction in all-cause mortality. The PVI procedure has been shown to be safe and comparably effective in treating Atrial Fibrillation (AF) in HFpEF patients, but no studies have yet demonstrated the effects of catheter ablation on exercise capacity or clinical outcomes. The investigators propose a prospective, non-blinded randomized control pilot study to assess the feasibility of conducting larger scale studies to determine if there are differences between catheter ablation with medical management on exercise capacity and quality of life in HFpEF patients with AF. The investigators' study will be powered for AF burden reduction, and the investigators hope to use the effect size on exercise capacity and heart failure events to help determine power for larger clinical studies that will follow to shed light on how invasive management of atrial fibrillation may impact the natural history of individuals with these two cardiovascular conditions.
研究者
入排标准
入选标准
- •between 18 to 90 years of age, male or female
- •Left Ventricular Ejection Fraction (LVEF) \> 50% by echocardiogram during routine screening or within 12 months prior to enrollment day.
- •Symptoms of heart failure requiring treatment with diuretic therapy for at least 30 days preceding enrollment.
- •Symptomatic paroxysmal or persistent atrial fibrillation.
- •Paroxysmal atrial fibrillation defined as recurrent AF (at least 2 episodes) that terminated spontaneously within 7 days
- •Persistent AF was defined as AF which is sustained beyond 7 days, or lasting less than 7 days but necessitating pharmacologic or electrical cardioversion
- •Included within the category of persistent AF is "long-standing persistent AF" defined as continuous AF of greater than 1 year in duration
- •AF episodes had to be documented in the last 3 months prior to enrollment by ECG, Holter monitor, Loop recorder, memory of the implanted device, or any suitable device.
- •Current symptoms of heart failure (NYHA II-IV) at the enrollment visit (Visit 1)
- •Structural heart disease evidenced by one or both of the following echocardiographic findings (done during the transthoracic echocardiography (TTE) within 6 months of enrollment)
排除标准
- •Previous left heart ablation procedure for AF
- •Contraindication to chronic anticoagulation therapy or heparin
- •Longstanding atrial fibrillation, defined here as greater than 3 years of persistent atrial fibrillation
- •Severe left atrial dilatation, with LA length \> 6.0 cm, optimally from parasternal long view
- •Acute coronary syndrome within 4 weeks as defined by electrocardiographic (ECG) ST segment depression or prominent T-wave inversion and/or positive biomarkers of necrosis (e.g. troponin) in the absence of ST-segment elevation and in an appropriate clinical setting (chest discomfort or angina equivalent).
- •Cardiac surgery, angioplasty, or cerebrovascular accident within 4 weeks prior to enrollment.
- •Planned cardiovascular intervention
- •Listed for heart transplant
- •Cardiac assist device implanted or need for mechanical hemodynamic support or inpatient admission
- •Life expectancy less than 1 year
结局指标
主要结局
Change in AF burden as assessed by difference in percentage of time an individual is in AF
时间窗: 3, 6, 9, and 12 months from intervention
AF burden, described as the percentage of time an individual is in AF relative to the total amount of time analyzed. This outcome will be assessed at multiple intervals following intervention arm, using a continuous, implantable heart rhythm monitor. The investigators' focus will be on the change between pre-intervention AF burden and AF burden at 6 month follow-up.
次要结局
- Number of heart failure hospitalizations(12 months)
- Change in exercise capacity as assessed by the 6 minute walk distance test(At baseline and 6 months post intervention)
- Change in NT pro-BNP levels(At enrollment (baseline) and 6 months following intervention)
- Number of all-cause hospitalizations(12 months)
- Change in patient-reported quality of life as assessed by Kansas City Cardiomyopathy Questionnaire(At enrollment (baseline) and 6 months following intervention)
- All-cause mortality(12 months)
- Number of cardiovascular mortalities(12 months)