Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation (PFA-VISION)
2026年8月13日 更新者：Stylianos Tzeis、Mitera Hospital
Intracardiac Echocardiography-guided Versus Electroanatomical Mapping-guided Pulsed Field Ablation for Paroxysmal Atrial Fibrillation - the PFA-VISION Randomized Trial (Pulsed Field Ablation - Visualization and Imaging Strategies for Isolation Outcomes in Paroxysmal Atrial fibrillatioN)
This is a prospective, randomized clinical trial, which will be conducted in selected European centers.
The objective is to compare two commonly used strategies to guide pulsed-field ablation (PFA) in patients with paroxysmal atrial fibrillation (AF).
Patients with paroxysmal AF planned to undergo PFA will be randomized to intracardiac echocardiography (ICE)-guided or electroanatomical mapping-guided (OPAL HDx mapping system) ablation procedure.
The primary efficacy endpoint will be freedom from atrial arrhythmia (AF, atrial flutter, atrial tachycardia) recurrence off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, with a follow-up duration of 12 months.
The primary safety endpoint will be the incidence of predefined safety outcomes.
研究概览
地位
招聘中
研究类型
介入性
注册 (估计的)
292
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Stylianos Tzeis, MD, PhD, FEHRA
- 电话号码：+302106869777
- 邮箱：steis@otenet.gr
学习地点
-
-
-
Zagreb、克罗地亚
- 尚未招聘
- University Hospital Centre Zagreb (KBC Zagreb)
-
接触：
- Vedran Velagić
- 电话号码：+38512388888
- 邮箱：vvelagic@gmail.com
-
-
-
-
-
Budapest、匈牙利
- 尚未招聘
- Heart and Vascular Center, Semmelweis University
-
接触：
- Nándor Szegedi
- 电话号码：+3614591500
- 邮箱：nandorszegedi@gmail.com
-
-
-
-
-
Athens、希腊
- 招聘中
- Hygeia Hospital, 8th Cardiology Department
-
接触：
- Stylianos Tzeis, MD, PhD, FEHRA
- 电话号码：+302106869777
- 邮箱：stzeis@otenet.gr
-
-
-
-
-
Ancona、意大利
- 尚未招聘
- Marche Polytechnic University / Marche University Hospital
-
接触：
- Michela Casella
- 电话号码：+390712206000
- 邮箱：m.casella@univpm.it
-
-
-
-
-
Prague、捷克语
- 尚未招聘
- Department of Cardiology, IKEM
-
接触：
- Petr Peichl
- 电话号码：+420236051111
- 邮箱：petr.peichl@ikem.cz
-
-
-
-
-
Banská Bystrica、斯洛伐克
- 尚未招聘
- Department of Arrhythmology, Institute of Cardiovascular Diseases
-
接触：
- Adrián Bystriansky
- 电话号码：+421484333111
- 邮箱：Adrian.Bystriansky@suscch.eu
-
-
-
-
-
Ljubljana、斯洛文尼亚
- 尚未招聘
- University Medical Centre Ljubljana (UKC Ljubljana)
-
接触：
- Matevž Jan
- 电话号码：+38615225050
- 邮箱：matevz.jan@kclj.si
-
-
-
-
-
Warsaw、波兰
- 尚未招聘
- Grochowski Hospital, Centre of Postgraduate Medical Education
-
接触：
- Jakub Baran
- 电话号码：+48225152733
- 邮箱：jakub.baran1111@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- History of paroxysmal AF.
- Scheduled to undergo AF catheter ablation with the FARAPULSE (Boston Scientific) PFA system.
Exclusion Criteria:
- Any contraindication to AF catheter ablation.
- History of previous left atrial ablation.
- Need for additional ablation beyond pulmonary vein isolation.
- Inability to provide written informed consent.
- Any factor that, in the investigator's judgment, renders the patient unsuitable for participation or may compromise their safety.
- eGFR < 30 mL/min/1.73 m2
- NYHA class III/IV heart failure
- Major cardiovascular events within 90 days
- Secondary AF owing to reversible causes
- Intracardiac thrombus or other conditions making left atrial instrumentation unsafe
- Severe valvular disease
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：ICE
Intracardiac echocardiography-guided group
|
Ablation procedure (electrical isolation of the pulmonary veins) will be performed according to routine clinical practice.
In the ICE group, positioning of the ablation catheter and confirmation of contact with the targeted tissue will be performed under ICE guidance.
In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping with the FARAVIEW system (OPAL HDx, software version 7.0, Boston Scientific).
PFA will be delivered using field-tag feature ensuring number of applications and stacking as suggested by IFU.
In the mapping group, the use of ICE will only be allowed to guide the transseptal puncture in order to ensure procedural safety in both groups.
|
|
其他：Mapping
Three-dimensional electroanatomical mapping-guided group
|
Ablation procedure (electrical isolation of the pulmonary veins) will be performed according to routine clinical practice.
In the ICE group, positioning of the ablation catheter and confirmation of contact with the targeted tissue will be performed under ICE guidance.
In the mapping group, guidance will be performed using three-dimensional electroanatomical mapping with the FARAVIEW system (OPAL HDx, software version 7.0, Boston Scientific).
PFA will be delivered using field-tag feature ensuring number of applications and stacking as suggested by IFU.
In the mapping group, the use of ICE will only be allowed to guide the transseptal puncture in order to ensure procedural safety in both groups.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Arrhythmia-free survival
大体时间：up to 12 months
|
Primary efficacy endpoint: Number of patients without atrial arrhythmia recurrence (AF, atrial flutter, atrial tachycardia) off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, after a blanking period of 2 months.
A recurrence is defined as any episode of atrial tachyarrhythmia recorded on standard 12-lead ECG or any episode lasting ≥6 minutes on Holter monitor (or CIED with atrial sensing capabilities).
|
up to 12 months
|
|
Complications
大体时间：up to 12 months
|
Composite primary safety endpoint: Number of participants experiencing at least one of the following prespecified complications (major safety events): Stroke, transient ischemic attack, or systemic embolism Coronary spasm Myocardial infarction Cardiac tamponade Clinically relevant esophageal complication Clinically relevant pulmonary vein stenosis Diaphragmatic paralysis persisting for more than 6 months Acute kidney injury Bleeding requiring transfusion Major vascular complication Pericarditis or vagal nerve injury Heart failure or pulmonary edema Sudden death within 30 days of the procedure Any device- or procedure-related death For the composite primary safety endpoint, each participant will be counted only once, regardless of the number or type of qualifying events experienced. |
up to 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Arrhythmia-free survial (>30 sec)
大体时间：up to 12 months
|
Number of patients without atrial arrhythmia recurrence (AF, atrial flutter, atrial tachycardia) lasting >30 seconds on Holter monitoring, off antiarrhythmic drug therapy and without the need for electrical cardioversion or repeat ablation, after an initial blanking period of 2 months.
|
up to 12 months
|
|
Procedure time (min)
大体时间：Periprocedural
|
Time from femoral puncture to catheter removal (minutes).
|
Periprocedural
|
|
Left atrial dwell time (min)
大体时间：Periprocedural
|
Time from transseptal puncture to catheter withdrawal from the left atrium (minutes).
|
Periprocedural
|
|
Number of lesions
大体时间：Periprocedural
|
Total number of ablation lesions deployed.
|
Periprocedural
|
|
Fluoroscopy time (min)
大体时间：Periprocedural
|
Duration of fluoroscopy (minutes).
|
Periprocedural
|
|
Fluoroscopy dose (cGy·cm²)
大体时间：Periprocedural
|
Total fluoroscopy dose (measured in cGy·cm²).
|
Periprocedural
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月1日
初级完成 (估计的)
2028年12月1日
研究完成 (估计的)
2028年12月1日
研究注册日期
首次提交
2026年8月10日
首先提交符合 QC 标准的
2026年8月13日
首次发布 (实际的)
2026年8月19日
研究记录更新
最后更新发布 (实际的)
2026年8月19日
上次提交的符合 QC 标准的更新
2026年8月13日
最后验证
2026年8月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.