Catheter Ablation for Atrial Fibrillation in Heart Failure With Preserved Ejection Fraction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Arrhythmia recurrence
研究概览
简要总结
Atrial fibrillation (AF) displays high prevalence in heart failure with preserved ejection fraction (HF-PEF) and compromises prognosis of affected patients. This study aims to assess catheter ablation (CA) for AF in patients with HF-PEF compared to AF-patients without systolic or diastolic dysfunction. Primary endpoints are freedom from AF and quality of life at 1 year. Furthermore, the study is designed to elucidate mechanistic characteristics distinguishing arrhythmic substrate and predicting AF-recurrence in patients with HF-PEF. For this purpose, left atrial concentrations of biomarkers for inflammation, fibrosis and neurohumoral activation are determined and hemodynamic measurements are performed periprocedurally.
Information on benefit from CA in these patients is necessary for clinical decision making and mechanistic investigations may point to tailored approaches in order to increase therapeutic efficiency.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Left ventricular ejection fraction ≥50%
- •Scheduled for catheter ablation of AF
排除标准
- •Significant valvular heart disease
- •Coronary artery disease with >70% stenoses or necessary coronary Intervention at time of recruitment
- •Coronary intervention 60 days before recruitment
- •Coronary bypass surgery 90 days before recruitment
- •Cardiomyopathy or cardiac storage disease (e.g. amyloidosis)
- •Reduced left ventricular ejection fraction
- •Pericardiac disease
- •Significant pulmonary hypertension
- •Chronic obstructive pulmonary disease with home-oxygen-therapy, oral steroids, hospitalization due to exacerbations during the last 12 months before recruitment, or suspected severe pulmonary condition based on clinical evaluation
- •Other non-cardiac conditions associated with limited physical capacity (adipositas permagna, severe anemia)
- •Pregnancy
- •Other limitations for adequate performance of stress echocardiography (e.g. orthopedic reasons)
结局指标
主要结局
Arrhythmia recurrence
时间窗: 12 months
Clinical arrhythmia and holter-recording
次要结局
- Diastolic left ventricular function in echocardiography(12 months)
- nTproBNP(12 months)
- Diastolic function in stressechocardiography(12 months)
- Troponin T(12 months)
- Systolic left ventricular function in echocardiography(12 months)
- PA-pressure in echocardiography(12 months)
- Quality of life questionnaire(12 months)
- 6-minute-walk-test(12 months)
研究者
Maura Zylla
Dr. med.
University Hospital Heidelberg