Electrophysiological Substrate Characterization of Paroxysmal and Persistent Atrial Fibrillation: PAPER-AF Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Analysis of the signals on ECG during sinus rhythm
研究概览
简要总结
Background and Hypothesis: Atrial Fibrillation (AF) treatment strategies have limitations. The efficacy of the procedure depends in several factors such as age, AF duration, atrial diameter and atrial electrophysiological behavior, determining what has been termed as atrial substrate. Therefore, the effectiveness of one specific treatment such as the ablation procedure, will be determined by the areas responsible for the maintenance of the fibrillation and its modification and/or elimination. The identification of these areas with a clear description of the arrhythmic substrate is one of the most important factors to determine new biomarkers that explain, at electrophysiological level, the properties of the substrate and therefore, increase the acute efficacy and long-term effectiveness of the treatment.
详细描述
The main objective of this project is to develop and validate new biomarkers based on a pre-existing methodology for the non-invasive identification of the mechanisms that are responsible for the maintenance of AF. This will be achieved by using a body surface potential mapping recording and using the signal to develop a new algorithm that is able to, from the acquired signals acquired during sinus rhythm, extract relevant features for an accurate prediction of long-term ablation outcome for patients with AF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with paroxysmal or persistent AF symptomatic and refractory to at least one antiarrhythmic medication arriving in sinus rhythm to the electrophysiology laboratory.
- •Patients must be able and willing to provide written informed consent to participate in the study.
- •Prior anticoagulation for> 4 weeks or transesophageal echocardiogram excluding intracardiac thrombi.
排除标准
- •Patients with inadequate anticoagulation levels, left atrial thrombus, tumor, or another abnormality which precludes catheter introduction on TEE prior to the procedure.
- •Patients with moderate-to-severe mitral regurgitation.
- •Patients with contraindications to systemic anticoagulation with heparin or coumadin.
- •Patients who are or may potentially be pregnant.
- •Current enrollment in another investigational drug or device study.
结局指标
主要结局
Analysis of the signals on ECG during sinus rhythm
时间窗: measurement will be performed at the inclusion point [0 months]
measuring P-wave maximum value \[milivolts\]
次要结局
- Analysis of the signals on ECG during sinus rhythm(1) measurement will be performed at the inclusion point [0 months])
研究者
Felipe Atienza
head of section (Cardiology Department)
Hospital General Universitario Gregorio Marañon