Long-term Outcomes in Long Standing Persistent Atrial Fibrillation Following Catheter Or Thoracoscopic Surgical Ablation : Extended Follow-Up Of CASA-AF Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Effectiveness of a single ablative procedure
研究概览
简要总结
Atrial fibrillation (AF) is a condition detected as an irregular heartbeat. It is the most common rhythm disturbance worldwide which can lead to significant symptoms and serious health problems (stroke and heart failure). The longer a person has AF, the more difficult it is to restore a normal heart rhythm. Those with continuous AF for longer than a year are described as having longstanding persistent AF (LSPAF). This is the most challenging type of AF to treat and medications are often not effective. Apart from medications patients with LSPAF may be offered a medical procedure to help improve their symptoms. It involves putting a flexible thin tube (catheter) into a blood vessel in the groin and up into the heart to destroy the tissue causing irregular heart beat. This procedure has modest success in improving symptoms in the long term. Recently, keyhole surgery has been used for these patients and evidence shows that it is better than the catheter procedure. However, we do not know how well people are doing beyond one year. Feedback from a patient focus group suggested that knowing the long-term results of these two procedures is important to help them make an informed choice when it comes to treatment. In this study we propose to continue monitoring patients from a randomised clinical trial (CASA AF RCT) who have already had one of the procedures. They have a small heartbeat monitor implanted under the skin with a battery life of around 3 years. We will be able to look at their heart rhythm data for the duration of this period and detect the return of the fibrillation if it happens.
详细描述
This study involves participants from the randomised clinical trial which was just completed (CASA AF RCT: NCT02755688; ISRCTN18250790 ). They have undergone relevant ablation procedures in a randomised fashion and completed 12 months follow up. At the last study visit they signed a consent form to confirm that they have agreed to keep implanted loop recorder for the duration of its battery life time (approximately 3 years). They have also continued to regularly transfer data from their implanted loop recorder to the secure server where it is regularly reviewed. This group of patients is now a unique cohort whose follow up data is invaluable for additional research. For this study we will ask for their written consent and apart from analysing their heart rhythm data we will arrange two hospital visits with some additional tests and completion of questionnaires.
The principal objective of the study is to compare the long-term effectiveness of thoracoscopic surgical ablation and percutaneous catheter ablation, the two procedures available for treatment of atrial fibrillation in patients with longstanding persistent AF (LSPAF). There is some evidence that thoracoscopic surgical ablation may be better than catheter ablation in keeping the patients in regular heart rhythm after a single procedure without use of antiarrhythmic drugs in short term. In this study we plan to monitor patients who have undergone these procedures for 3 years.
Our secondary objectives are focussing on patients who had more than one procedure and/or may be using medications in order to maintain regular heart rhythm during 36 months follow up.
We will therefore look at:
- the effectiveness of a single procedure (catheter or surgical) in maintaining normal rhythm with use of antiarrhythmic drugs.
- the effectiveness of multiple ablative procedures in maintaining sinus rhythm with and without use of antiarrhythmic drugs.
- the proportion of patients who are still in AF but the time they spend in it is reduced by ≥75%.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •CASA-AF RCT participants who have undergone ablative procedure to treat their LSPAF, completed 12 months follow up and consented to keep their implanted loop recorders in situ with weekly data downloads.
排除标准
- •There are no exclusion criteria for this study.
结局指标
主要结局
Effectiveness of a single ablative procedure
时间窗: over the duration of the followup period (24 months)
Freedom from continuous atrial arrhythmia (≥120 seconds in duration) recorded by implantable loop recorder or other clinically indicated rhythm recording device and absence of anti-arrhythmic drugs on concurrent medications form.
次要结局
- AF related quality of life(at 24 and 36 months from the ablative treatment)
- Reduction of burden of atrial fibrillation(over the duration of the followup period (24 months))
- Quality of life assessment(at 24 and 36 months from the ablative treatment)
- Changes in concentration of serum biomarkers (pg/ml)(from baseline to 36 months after the ablative procedure)