Pulsed Field Ablation During Left Atrial Appendage Occlusion: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in quality of lfie
研究概览
简要总结
Atrial fibrillation (AF) is the most common abnormal heart rhythm. It is also a leading cause of stroke, due to blood clots forming within an area called the 'left atrial appendage'. Usually, blood thinners (anticoagulants) are given to patients to reduce this risk. However, some patients are not able to take these medications due to a high bleeding risk. In this situation, these patients are sometimes offered a 'left atrial appendage occlusion' (LAAO) procedure - this is performed by inserting wires through the veins in the groin into the heart, then deploying a device which blocks the appendage, thus stopping blood clots from forming. There is increasing interest within our professional community of combining this procedure with another, called 'catheter ablation', which is performed to improve the symptoms of AF. This procedure uses similar access to the heart, but is not often performed in the same sitting - and often not performed at all in this patient group as they are felt to be at higher risk of complications due to bleeding or clotting. Pulsed Field Ablation (PFA) is a new technology which significantly improves safety of ablation. In this randomised controlled trial, patients referred for LAAO will be randomised to receive LAAO+PFA (intervention) or LAAO alone (control). Patients will be blinded to treatment received, which allows thorough assessment of the benefit of ablation.
详细描述
- Background and Study Rationale
Catheter ablation for atrial fibrillation (AF) has been associated with improvement in quality of life outcomes1 and even a reduction in stroke risk. Left atrial appendage occlusion (LAAO) is an effective option for preventing thromboembolic strokes in patients with AF. It is most indicated in those who have a high stroke risk but have contraindications to oral anticoagulant (OAC) therapy, such as a prior haemorrhagic stroke.
LAAO is an invasive procedure and hence carries a degree of risk. Many of these risks are common to those encountered during a standard AF ablation procedure, which is routinely performed for symptomatic improvement (rhythm control) of AF. Both procedures require femoral venous access and trans-septal puncture to access the left atrium (LA). These procedures have traditionally been performed at separate time points, largely due to the long procedure duration for AF ablation and resulting long LA dwell time (which is associated with increased risk of thromboembolic procedural complications). However, the disadvantage is a cumulative increased risk of other complications, especially with repeated vascular access and the need for two trans-septal punctures with this approach.
The advent of PFA as a new modality for AF ablation now means that AF ablation can be performed very quickly, with LA dwell times of 15-20 minutes compared to more conventional methods of up to 2 hours. Given that LAAO itself also requires an LA dwell time of 15-20 minutes, this makes it feasible and indeed attractive to perform both procedures simultaneously in suitable patients. Whilst this would increase the LA dwell time, it would remain comparable to prior ablation technologies (which carry a proven safety record) and would reduce the risk of other complications caused by a second procedure (e.g., vascular damage, cardiac tamponade, etc).
The optimal patient population, and procedure-related outcomes, for this combined procedure have not been studied. 2. Hypothesis
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
- Single (Participant)
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
- •Paroxysmal or Persistent AF, aged 18-80
- •Presence of symptoms attributable to AF: EHRA 2 and above
- •Clinical indication for LAAO procedure
- •Own smartphone compatible with AliveCor device
排除标准
- •Permanent AF
- •Body mass index ≥40
- •Previous LA ablation procedure
- •Severely enlarged LA (>50mm antero-posterior diameter)
- •Severely impaired left ventricular function (ejection fraction < 35%)
- •Severe valvular disease
- •Significant renal impairment (estimated glomerular filtration rate < 30)
- •Pregnancy
- •Significant frailty (Clinical Frailty Score < 5)
- •Non-AF arrhythmia (e.g., atypical flutter, focal atrial tachycardia, other narrow complex tachycardias)
- •Inability to provide informed consent
结局指标
主要结局
Change in quality of lfie
时间窗: Measured at baseline and at 12 months following the procedure
Change in quality of life from baseline to 12 months as measured by the Atrial Fibrillation Effect On Quality-Of-Life Questionnaire (AFEQT) questionnaire
次要结局
- Procedural safety outcomes(From the day of the procedure to end of follow-up at 12 months)
- Procedural metrics(On the day of the left atrial appendage +/- pulsed field ablation procedure)
- Time to atrial fibrillation recurrence(From the day of the procedure to end of follow-up at 12 months)
- Requirement for unplanned further ablation or cardioversion procedures(From the day of the procedure to end of follow-up at 12 months)