Procedural Comparative Evaluation of Pulmonary Vein Isolation Using the FARAWAVE Nav PFA Catheter Without Pre-Ablation Computer Tomography (CT) vs. Conventional Farapulse With Pre-Ablation CT: A Single Centre Open-label, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Fluoroscopy time
研究概览
简要总结
The FARAPULSE PFA catheter (Boston Scientific), a first-generation Pulsed Field Ablation (PFA) tool, has demonstrated good performance in isolating pulmonary veins (PV). Several centers, including ours, utilize pre-procedural computer tomography (CT) to evaluate individual pulmonary vein anatomy and optimize ablation planning. However, these imaging modalities are costly. Additionally, CT imaging exposes patients to radiation, and introduce significant logistical challenges to the procedural workflow.
The FARAWAVE Nav PFA catheter, a second-generation device, integrates magnetic navigation capabilities with detailed mapping and PFA therapy into a single tool. This system leverages the FARAVIEW Software Module, offering tailored mapping solutions visualized on the FARAPULSE PFA system, including the creation of voltage and activation maps.
These features address the limitations of the first-generation FARAPULSE catheter and have the potential to improve procedural accuracy and the durability of pulmonary vein isolation. Moreover, they may obviate the need for pre-procedural CT, thereby reducing costs and minimizing patient radiation exposure.
Our study evaluates whether the FARAWAVE Nav catheter, used without pre-ablation CT, allows for a reduction in fluoroscopy time and overall patient radiation exposure compared to the conventional workflow with the FARAPULSE catheter. Furthermore, we will assess procedural time, costs, number of PFA applications, and AF recurrence-free survival
详细描述
The FARAPULSE PFA catheter (Boston Scientific), a first-generation Pulsed Field Ablation (PFA) tool, has demonstrated good performance in isolating pulmonary veins (PV) as standard of care for atrial fibrillation (AF) ablation. Several centers, including ours, utilize pre-procedural CT or cardiac magnetic resonance (CMR) imaging to evaluate individual pulmonary vein anatomy and optimize ablation planning. However, these imaging modalities are costly. Additionally, CT imaging exposes patients to radiation, and both CT and CMR add significant logistical challenges to the procedural workflow.
The FARAWAVE Nav PFA catheter, a second-generation device, integrates magnetic navigation capabilities with detailed mapping and PFA therapy into a single device. This system leverages the FARAVIEW Software Module, offering tailored mapping solutions visualized on the FARAPULSE PFA System, including the creation of voltage and activation maps. Key technical enhancements of the FARAWAVE Nav PFA catheter include: Field Tag Technology: Field tagging estimates field volume and indicates energy delivery locations. Tags confirm overlap between applications, ensuring comprehensive PV isolation. Voltage/Activation Maps: Mapping data enhances procedure precision, allowing visualization of electrical activation and PV anatomy without reliance on pre-ablation CT imaging. These features address the limitations of the first-generation FARAPULSE catheter and have the potential to enhance procedural accuracy and the durability of pulmonary vein isolation. Moreover, they may eliminate the need for pre-procedural CT or CMR, thereby reducing costs and minimizing patient exposure to radiation.
Our center, like several others, has used the first-generation catheter in routine clinical practice for over a year. More recently, we have also started using the second-generation catheter as part of standard clinical care. Currently, the two devices are used interchangeably, depending on logistical availability, particularly the presence of specialized technicians from Boston Scientific, who are required for the proper operation of the second-generation catheter.
Our study evaluates whether the FARAWAVE Nav catheter, without pre-ablation CT, allows to reduce fluoroscopy time and total patient radiation load as compared to conventional workflow with FARAPULSE catheter. Furthermore, procedural time, costs, number of PFA applications and AF recurrence free survival will be assessed.
Inclusion Criteria
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atrial fibrillation (AF) documented on a 12-lead ECG, Holter monitor, or implantable cardiac device.
- •Candidate for ablation according to current atrial fibrillation guidelines.
- •Age ≥18 years at the time of informed consent.
- •Signed informed consent obtained
排除标准
- •Previous left atrial ablation or left atrial surgery.
- •Presence of intracardiac thrombus.
- •Persistent atrial fibrillation lasting >3 years.
- •Severe mitral regurgitation or moderate-to-severe mitral stenosis.
- •Pregnancy (all women under 50 years undergo an HCG blood test prior to inclusion to exclude pregnancy).
研究组 & 干预措施
Intervention
FARAWAVE Nav without pre-ablation CT
干预措施: Second-generation FARAWAVE Nav catheter without the use of pre-ablation CT (Device)
Control
FARAPULSE with pre-ablation CT
干预措施: FARAPULSE with pre-ablation CT (Device)
结局指标
主要结局
Fluoroscopy time
时间窗: immediately after the procedure
The primary outcome of this investigation is fluoroscopy time, measured in minutes during the pulmonary vein isolation procedure. This outcome was chosen because it directly reflects the amount of radiation exposure experienced by the patient and is a critical measure of procedural efficiency and safety. For patients undergoing PVI plus additional left or right atrial ablations (planned or unplanned) the fluoroscopy time will be counted until the last application of the PVI. Fluoroscopic times will be compared between groups using the unpaired Student t test. The mean difference and 95%CI will be computed. In case of skewness, data will be log-transformed before entering the test. In this the mean difference on the log scale and the ratio on the original scale will be presented, both with 95%CI.
次要结局
- Total Patient Radiation Load(immediately after the procedure)
- Fluoroscopy Time After Transseptal Puncture(immediately after the procedure)
- Number of PFA Applications(immediately after the procedure)
- Procedure Time(immediately after the procedure)
- Left Atrial Dwelling Time(immediately after the procedure)
- AF Recurrence-Free Survival(up to 6 months)
- AF Burden(up to 6 months)
研究者
Marco Bergonti
MD PhD
Cardiocentro Ticino