Radiofrequency Ablation for Atrial Fibrillation in Advanced Chronic Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)
研究概览
简要总结
Heart failure is a condition that occurs when the heart muscle weakens and no longer contracts normally. Half of these patients have an irregularity of heart rhythm called atrial fibrillation (AF). Patients with both heart failure and AF spend more time in hospital, and die earlier than those with heart failure alone. AF is difficult to treat with conventional methods in patients with heart failure. Radiofrequency ablation is a new technique used to cure AF. The investigators aim to establish if radiofrequency ablation for atrial fibrillation in patients with advanced heart failure can result in marked improvement in the function of the heart.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Persistent atrial fibrillation (AF)
- •New York Heart Association (NYHA) II, III and IV chronic heart failure (CHF) despite optimal medical therapy for at least 3 months
- •left ventricular ejection fraction (LVEF) <35% - as measured by radionuclide ventriculography (RNVG)
- •Patients with CHF secondary to ischaemic and non-ischaemic aetiology
排除标准
- •QRS duration >150ms (or QRS 120-150 with evidence of mechanical cardiac dysynchrony)
- •Magnetic resonance imaging (MRI) - incompatible metallic (ferrous) prosthesis
- •Primary valvular disease as a cause of CHF
- •Reversible causes of CHF
- •Acute myocarditis
- •Patients aged 18 or less
- •Patients having undergone revascularisation procedures within 6 months
- •Paroxysmal AF
- •Pregnancy
- •Expected cardiac transplantation within 6 months
研究组 & 干预措施
medical therapy
Standard therapy for heart failure with angiotensin converting enzyme inhibitors(ACE) - (Ramipril, enalapril, lisinopril, captopril, perindopril), beta-blocker (BB) - (carvedilol, bisoprolol, metoprolol), Aldosterone antagonists (spironolactone) +/- diuretics and digoxin
干预措施: ACE inhibitor - ramipril, enalapril, captopril, perindopril, lisinopril (Drug)
medical therapy
Standard therapy for heart failure with angiotensin converting enzyme inhibitors(ACE) - (Ramipril, enalapril, lisinopril, captopril, perindopril), beta-blocker (BB) - (carvedilol, bisoprolol, metoprolol), Aldosterone antagonists (spironolactone) +/- diuretics and digoxin
干预措施: Beta Blocker (BB) - metoprolol, bisoprolol, carvedilol (Drug)
medical therapy
Standard therapy for heart failure with angiotensin converting enzyme inhibitors(ACE) - (Ramipril, enalapril, lisinopril, captopril, perindopril), beta-blocker (BB) - (carvedilol, bisoprolol, metoprolol), Aldosterone antagonists (spironolactone) +/- diuretics and digoxin
干预措施: Aldosterone Antagonists - spironolactone (Drug)
Radiofrequency ablation (RFA)
Isolation of the pulmonary veins using radiofrequency ablation
干预措施: radiofrequency ablation (Procedure)
结局指标
主要结局
Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)
时间窗: Baseline
Baseline Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)in %
Change in Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)%
时间窗: baseline and 6 months
left ventricular ejection fraction (LVEF) is a measure of the % of blood ejected from the ventricle in one heart beat. It is a measure of cardiac function. We measured LVEF at baseline and at 6 months, to assess whether there had been a change in the patients cardiac function over time.
Left Ventricular Ejection Fraction by Magnetic Resonance Imaging (MRI)at 6 Months
时间窗: 6 months
Left Ventricular Ejection Fraction as measured by Magnetic Resonance Imaging (MRI)at 6 months
次要结局
- Plasma B-type Natriuretic Peptide (BNP)(baseline and 6 months)
- Plasma B-type Natriuretic Peptide (BNP) at Baseline(Baseline)
- Plasma B-type Natriuretic Peptide (BNP) at 6 Months(6 months)
研究者
Michael MacDonald
Cardiology ST6
NHS Greater Glasgow and Clyde