Low-VOLTage Area-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter (LowVOLT-AF)
LowVOLT-AF Study: Low-VOLTage Areas-Guided Catheter Ablation and SVC Isolation for Persistent Atrial Fibrillation Using a Balloon-in-Basket Pulsed Field Ablation Catheter
The primary objective of this study is to determine whether low-voltage areas (LVA)-guided catheter ablation combined with superior vena cava (SVC) isolation and pulmonary vein isolation (PVI), performed using the balloon-in-basket Volt™ pulsed field ablation PFA system, is superior to PVI alone using same technology in reducing arrhythmia recurrence at 6 and 12 months in patients with persistent AF and detectable significant LVAs on three-dimensional electroanatomical mapping.
Moreover, the study will investigate, in a separate randomized cohort, the effect of adding SVC isolation to PVI using the balloon-in-basket Volt™ PFA system, compared with PVI alone, in patients with persistent AF without detectable significant LVAs during three-dimensional electroanatomical mapping.
研究概览
地位
条件
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Roland R Tilz
- 电话号码:+49 451 500-44511
- 邮箱:roland.tilz@uksh.de
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion criteria
Participants must meet all the following criteria:
- Age ≥18 years
- Persistent AF, defined as continuous AF lasting at least 7 days
- Indication for catheter ablation according to the latest ESC guidelines
- Written informed consent
Exclusion criteria
Participants will be excluded if any of the following criteria apply:
- Inability or unwillingness to provide informed consent
- Continuous AF duration duration of ≥2 years
- Documented atrial tachycardia or atrial flutter
- Previous left atrial catheter ablation or cardiac surgery
- Planned cardiac surgery within the first 3 months after inclusion
- History of heart transplantation, current listing for transplantation, or planned cardiac assist device implantation
- Severe mitral or aortic valvular disease, according to the ESC guidelines
- Platelet count <50,000 cells/mm³
- Body mass index >45 kg/m² or <18 kg/m²
- Untreated thyroid dysfunction (patients may be included once hypothyroidism or hyperthyroidism is adequately treated)
- Absolute contraindication to oral anticoagulation
- Any comorbidity that limits life expectancy to <1 year
- Active systemic infection (enrolment permitted after successful treatment)
- Women who are pregnant or breastfeeding
- Women of childbearing potential not using highly effective contraception (PEARL Index <1%)
- End-stage renal disease (GFR <15 ml/min/1.73 m2) or hepatic failure (Child Pugh C)
- Acutely decompensated heart failure (NYHA IV), inclusion is possible only after stabilization to a NYHA functional status better than IV
- Participation in another randomized controlled trial
学习计划
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 |
|---|---|
|
实验性的:LVA-guided catheter ablation combined with SVC isolation and PVI
|
SVC isolation
PVI alone
|
|
有源比较器:LVA-guided catheter ablation combined with PVI alone
|
SVC isolation
PVI alone
|
|
实验性的:SVC isolation and PVI in patients without detectable significant LVA
|
SVC isolation
PVI alone
|
|
有源比较器:PVI alone in patients without detectable significant LVA
|
SVC isolation
PVI alone
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Recurrence of atrial arrhythmias defined as atrial fibrillation, atrial flutter or atrial tachycardia lasting ≥30 seconds occurring after a 2-month post-procedural blanking period.
大体时间:within 6 months following catheter ablation.
|
within 6 months following catheter ablation.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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