Comparison Between VEin of MArshall Ethanol Infusion Versus Extended Pulmonary Vein PULSEd Field Ablation After Failed Pulmonary Vein Isolation in Patients with Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Atrial tachyarrhythmia recurrence within 12 months
研究概览
简要总结
The goal of this clinical trial is to compare two ablation techniques to treat patients with persistent atrial fibrillation (irregular and often very rapid heart rhythm). An ablation is a procedure during which some scars are made on the inside of the heart to break up the electrical signals that cause the irregular heartbeat. In this trial researchers will compare a new technique, which uses tiny electric shocks to make the scars, to the standard technique, which uses heat.
The main question the trial aims to answer is:
• Does the new technique work as well as the standard technique to prevent the irregular heartbeat from returning within one year of the procedure?
Participants will:
- Undergo an ablation with either the new or the standard technique
- Visit the hospital 1, 3, 6, 9 and 12 months after the procedure for a check-up
- Wear a device to register their heart rhythm for 24 hours before the 3 month visit and for 72 hours before the 6, 9 and 12 month visit
- Record their heart rhythm at home every week
- Complete a questionnaire 3, 6, 9 and 12 months after the procedure
详细描述
Background
Pulmonary vein isolation (PVI) remains the cornerstone of catheter ablation for the treatment of atrial fibrillation (AF). However, in patients with persistent AF, recurrence occurs in 20% to 50% of the patients. These patients often need additional ablation beyond PVI in the index procedure or in a redo procedure. During redo procedures, optimal management of AF has not been validated yet. Different strategies are used but without strong scientific background and without uniformity.
In the case of PV reconnection, PV re-isolation alone seems to be the gold standard in healthy atria, but with moderate success in patients with dilated left atrium or scar zones.
Different recent studies show a potential impact of posterior wall isolation; however with discordant results. This could be in part related to low rate of durable posterior wall isolation and also due to potential risk of esophageal fistula limiting the use of RF ablation at the posterior wall. The use of pulsed field energy could improve lesion durability and avoid any risk of fistula.
On the other hand, ethanol infusion in the vein of Marshal has also been shown to improve the success rate of persistent AF ablation but requires significant experience and may be time-consuming.
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
- •Symptomatic persistent atrial fibrillation (AF) despite a first PVI. Persistent AF is defined as the presence of AF lasting ≥7 days (i.e. in case of new onset AF one has to wait for 7 days)
排除标准
- •Persistent AF lasting ≥ 12 months
- •Advanced valvular heart disease
- •Left atrial (LA) volume >150mL
- •LA diameter (PS-LAX) >60mm
- •Septal wall diameter >15mm
- •Life expectancy <1 year
- •Weight >150 kg
- •Any contra indication to catheter ablation
结局指标
主要结局
Atrial tachyarrhythmia recurrence within 12 months
时间窗: 2-12 months
Percentage of patients with any atrial tachyarrhythmia recurrence (\> 30 sec) from 2 months (blanking period) to 12 months after the ablation procedure
次要结局
- Duration of the ablation procedure(During procedure)
- Fluoroscopy time(During procedure)
- Unscheduled visits and hospitalization(12 months)
- Fluoroscopy dose(During procedure)
- Safety and procedural related adverse event(During procedure-12 months)
- Effect of the procedure on quality of life(3, 6, 9, 12 months)
- Incidence of repeat ablation(12 months)
研究者
Sebastien Knecht
Principal Investigator
AZ Sint-Jan AV