ELectrocardiographic Imaging-guided Substrate Ablation in Patients With Atrial Fibrillation - a PILOT Study of a Personalized Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Acute AF termination
研究概览
简要总结
The goal of this pilot study is to test if noninvasive global mapping can guide catheter ablation defining personalized targets and improve the therapy of atrial fibrillation. It will also test the safety of such an approach. The main questions it aims to answer are:
- Does ablation of targets defined by noninvasive 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 noninvasive 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 and 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
- 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
Acute AF termination
时间窗: Procedural
Rate of acute AF termination (ro 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)
- Rate of procedure-related complications(Day 0 to 30 post-ablation)
研究者
Ivo Roca
Head of Arrhythmia Unit. Cardiovascular Institute. Hospital Clinic
Hospital Clinic of Barcelona