Triple Atria Extrastimuli vs Pulmonary Vein Isolation Alone in Persistent Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Number of patients with lower burden of atrial fibrillation during follow-up comparing both arms
研究概览
简要总结
The problem addressed in this proposal is related to the success rate in treating one of the most common arrhythmias in the Western population, atrial fibrillation (AF). Specifically, the success rate is particularly low in persistent atrial fibrillation, being up to 40% lower than the success rate for paroxysmal atrial fibrillation.
Atrial fibrillation is associated with increased mortality and morbidity (stroke, heart failure, dementia, etc.). The most effective treatment is electrical isolation of the pulmonary veins (PVI) by catheter ablation using radiofrequency or cryoablation of the atrial myocardial tissue. This ablation allows the elimination of the main initiators of the arrhythmia but may not address its maintainers, which play a significant role in persistent atrial fibrillation.
This project proposes a new approach in studying the atrial myocardial substrate for persistent fibrillation ablation. Until now, maintainers of the arrhythmia have been sought by conducting studies during atrial fibrillation. In this project, we will use short-coupled stimulation techniques during sinus rhythm and analyze the response of the atrial myocardium, attempting to unmask areas where the impulse propagates abnormally/slowly. These areas of the atrial muscle with hidden slow conduction (HSC) could generate short circuits that maintain atrial fibrillation. It would be expected that these areas would show fragmented electrograms in response to rapid electrical stimuli not visible in basal rhythm.
The study is divided into two sub-studies to be carried out over the 3-year project.
- This study aims to test the feasibility of this new arrhythmic substrate characterization strategy, as well as observe differences between patients with paroxysmal and persistent AF and compare it with conventional fragmented electrogram analysis during AF.
- The second sub-study will apply the knowledge acquired during the first phase regarding the characterization of electrograms-HSC, allowing for radiofrequency ablation procedures to be performed using a new substrate ablation technique consisting of the elimination of these electrograms and comparing the results with those patients who undergo conventional pulmonary vein ablation techniques.
The ultimate goal, from a global point of view, is to demonstrate that it is possible to improve the results of arrhythmia treatment by identifying and eliminating these electrograms-HSC.
详细描述
STUDY PURPOSE The aims of the current study are
- To investigate the presence, characteristics and location of complex electrograms suggestive of slow conduction zones elucidated by triple atria extrastimuli during sinus rhythm in paroxysmal and persistent Atrial Fibrillation (AF)
- Correlate atrial HSC- electrograms during sinus with continuously fractionated electrograms during AF in patients with persistent AF
- Test the hypothesis that elimination of atrial HSC-Electrograms(EGM) in addition to PVI would improve ablation outcomes in PersistentAF(PsAF) patients versus PVI alone in a randomized study.
Sub-study 1 (ANALYSIS OF HIDDEN SLOW CONDUCTION ELECTROGRAMS IN PAROXISMAL AND PERSISTENT ATRIAL FIBRILLATION. HSC-AF STUDY):
1.1. OBJETIVES HYPOTHESIS Left atrial EGM showing HSC elucidated by atria extrastimuli should be more manifest in persistent versus paroxysmal AF and should de more spatially and temporarily reproducible compared to fractionated EGM during AF STUDY OBJETIVES 1.1 Describe the method to elucidate HSC using a triple atrial extrastimuli 1.2 Analyze the characteristics and location of HSC-EGMs 1.3 Compare the presence, burden, characteristics and location of HSC-EGMs in paroxysmal versus persistent AF 1.4 Compare the presence and location of HSC-ECGs with fractionated EGM during AF
1.2. METHODS Summary of methods: 10 patients with paroxysmal AF and 10 patients with PsAF who undergoing a first-time ablation procedure for AF will be consecutively included to describe the complex electrograms (presence, distribution, number of deflections, amplitude, duration, delta of EGM width) elucidated by triple atria extrastimuli during sinus rhythm.
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
- Single (Participant)
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
- •Age > 18 years.
- •Patients undergoing a first-time ablation procedure for AF.
- •Patients with persistent or long-lasting AF; persistent AF will be defined as a sustained episode lasting >7 days and <1 year; long-lasting persistent AF will be >1 year and <3 years
- •Patients with PxAF; PxAF will be defined as a sustained episode lasting <7 days;
- •Patients who must be willing and able to comply with all periablation and follow-up requirements
- •Patients with AF who will accept the procedure of ablation
- •Patients who signed the written informed consent for the study
- •Patients who can endure the required follow-up.
排除标准
- •Patients with left atrial size ≥55 mm (2-dimensional echocardiography, parasternal long-axis view)
- •Patients with severe structural cardiac disease (severe mitral regurgitation, dilated cardiomyopathy, hypertrophy cardiomyopathy, other severe valvular heart diseases)
- •Patients with the serum creatinine >3.5 mg/dL or creatinine clearance rate <30 mL/min;
- •Patients with life expectancy <12 months;
- •Medical, geographical and social factors that make study participation impractical, and inability to give written informed consent. Patient's refusal to participate in the study.
结局指标
主要结局
Number of patients with lower burden of atrial fibrillation during follow-up comparing both arms
时间窗: This outcome will be analyzed during the last 8 months of the project
It will be assessed through a 24-hour holter monitor during follow-up the burden of atrial fibrillation in both study arms. It will be evaluated whether the elimination of HSC-EGM along with PVI will improve the outcomes in Persistent AF compared to those in which only PVI is performed.
次要结局
- Number of Participants With Treatment-Related Adverse Events(This outcome will be analyzed during the recruitment period, starting on the 9th month with a duration of 20 months)
研究者
Juan Fernandez-Armenta Pastor
PhD MD
Instituto de investigación e innovación biomédica de Cádiz