Understanding the Role of Right Atrial Ectopy-triggering Ganglionated Plexuses in Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- atrial arrhythmia lasting >30secs
研究概览
简要总结
Atrial fibrillation (AF) is the most common rhythm disturbance of the heart. It can affect people of any age but usually happens as we get older. It can cause palpitations, breathlessness, lethargy, and fainting attacks. It is also associated with an increased risk of strokes.
The best treatment for it at the moment involves burning or freezing (ablation) the heart muscle in a part of the heart called the left atrium. The ablation injures the heart muscle around the so-called pulmonary veins and the procedure is called a 'pulmonary vein isolation'. This procedure work in about 60% of people.
The study team have found that there are nerve endings in the heart that also cause AF and have shown that ablating these nerve endings also prevents AF. These Nerve endings are known as ganglionated plexuses (GPs).
The study team would now like to perform a trial in people who still have AF after the usual pulmonary vein procedure. The study team hope that ablating the nerve endings that cause AF (GPs), we will stop their AF coming back. The study team will compare this procedure to the normal approach of doing the pulmonary vein isolation again
详细描述
Atrial fibrillation (AF) is the most common heart rhythm disturbance and causes physical discomfort and strokes.
The the best long-term treatment of AF is catheter ablation in a part of the heart called the left atrium and works in about 60-70% of patients.
The study team have discovered that that there are nerve endings in the heart that cause AF (GP sites). The study team have previously treated patients with AF by ablating these nerve endings (GP ablation) in a part of the heart called the left atrium.
The study team have treated patients with AF by ablation of these nerve ending in the left atrium. The treatment worked in a similar number of people to the standard treatment but caused less heart injury than the standard treatment
There are similar nerve endings in another part of the heart called the right atrium. The study team want to find out if ablating these nerve endings in the right atrium can help people for whom the standard treatment in the left atrium has not worked.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females from 18 to 85yrs old
- •Symptomatic paroxysmal atrial fibrillation
- •Suitable candidate for catheter ablation
- •Signed informed consent
排除标准
- •Contraindication to catheter ablation
- •Contraindication for general anaesthetic
- •Presence of a left ventricular thrombus
- •Valvular disease that is grade moderate or greater
- •Any form of cardiomyopathy
- •Severe cerebrovascular disease
- •Active gastrointestinal bleeding
- •Serum Creatinine >200umol/L/ on dialysis/ at risk of dialysis
- •Active infection or fever
- •Life expectancy shorter than the duration of the trial
- •Allergy to contrast
- •Moderate to severe heart failure and/or NYHA Class III-IV
- •Bleeding or clotting disorders or inability to receive heparin
- •Uncontrolled diabetes (HbA1c ≥73mmol/mol or HbA1c ≤64mmol/mol and Fasting Blood Glucose ≥9.2mmol/L)
- •Malignancy needing therapy
- •Pregnancy or women of childbearing potential not using a highly effective method of contraception
- •Unable to give informed consent
结局指标
主要结局
atrial arrhythmia lasting >30secs
时间窗: 1 year
Any recorded atrial arrhythmia lasting \>30seconds will meet the primary endpoint for the trial.
次要结局
- Quality of life questionnaire(1 year)
- Complications(1 year)
- Re-do procedures(1 year)
- Usage of antiarrhythmic drugs(1 year)
- Radiofrequency time(day of the procedure.)