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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 618
研究概览
简要总结
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
- •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
排除标准
- •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
研究者
Roland Richard Tilz, MD
Director, Department of Rhythmology, University Heart Center Lübeck
University of Luebeck