Personalized Atrial Fibrillation Ablation Guided by Non-Invasive Global Mapping - the CURE-AF Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 5
- 主要终点
- Rate of acute AF termination
研究概览
简要总结
This pilot study investigates if non-invasive global mapping can guide catheter ablation of atrial fibrillation (AF) by defining personalized targets based on the temporal Stability of local Atrial High-Rate Activity (SAHRA). The study also assesses efficacy and safety of this approach and evaluates potential signals of harm. The main questions it aims to answer are:
- Does ablation of targets defined by non-invasive global mapping improve rates of acute atrial fibrillation termination?
- Does such a personalized ablation approach reduce arrhythmia recurrence rates? Researchers will compare the results of the personalized ablation approach with comparable patients that had undergone a conventional "empirical" ablation approach (pulmonary vein isolation).
Participants will:
- Undergo a personalized catheter ablation approach employing both a non-invasive global mapping system and a conventional intracardiac mapping system
- Visit the clinic 3, 6 and 12 months after ablation for clinical follow-up
- Schedule a telephone visit 9 and 24 months after ablation for clinical follow-up
详细描述
The aim of this study is to test the feasibility and potential of a personalized, non-invasive mapping-guided ablation approach in patients with persistent atrial fibrillation (AF), who are unlikely to benefit from empirical pulmonary vein isolation alone. As a pilot study, it is designed to assess feasibility and procedural efficacy as well as potential signals of harm.
General Strategy:
Patients with persistent AF planned for catheter ablation are eligible in case of left atrial enlargement.
The study intervention consists of two steps:
- Empirical pulmonary vein isolation in all patients (current standard of care).
- A personalized ablation approach targeting up to three additional atrial regions which harbour critical AF-perpetuating sources:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Ablation-naïve patients with:
- •Persistent AF planned for catheter ablation plus
- •Left atrial enlargement (LA diameter ≥45 mm or LA volume index ≥35ml/m2 or LA area ≥20 cm2)
排除标准
- •Previous cardiac ablation
- •Age <18 years
- •Pregnancy or lactation
- •Previous stroke/TIA
- •Severe left ventricular dysfunction (LVEF <35%)
- •Renal failure (GFR <30 ml/min)
- •Dermal disease or hypersensitivity predisposing for skin irritation or exanthema
研究组 & 干预措施
Non-invasive mapping-guided ablation
In this arm patients undergo a personalized ablation approach: In addition to conventional pulmonary vein isolation, additional target regions will be ablated based on non-invasive global mapping.
干预措施: Non-invasive mapping-guided ablation (Procedure)
结局指标
主要结局
Rate of acute AF termination
时间窗: Procedural
Acute AF termination (to sinus rhythm or conversion into an organized atrial tachycardia) upon ablation
次要结局
- Proportion of patients with arrhythmia-free survival(Days 91 to 365 post-ablation)
- Proportion of patients with AF-free survival(Days 91 to 365 post-ablation)
- Time to arrhythmia recurrence(Days 91 to 365 post-ablation)
- Time to AF recurrence(Days 91 to 365 post-ablation)
- Rate of procedure-related complications(Day 0 to 30 post-ablation)
研究者
Till Althoff
Head of Research and Principal Investigator
German Heart Institute