A Single-center, Observational, 12-months Study to Examine the Predictive Factors for Successful Outcome After Pulmonary Veins Ablation to Treat Patients With Paroxysmal Atrial Fibrillation.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Number of Paroxysmal Atrial Fibrillation (PAF) relapse(s)
研究概览
简要总结
Atrial fibrillation is the most common serious abnormal heart rhythm affecting about 2% to 3% of the population, being associated with a 1.5- to 1.9-fold higher risk of death. Patients with paroxysmal AF in whom antiarrhythmic drug therapy does not elicit a response are potential candidates for RF ablation of AF. The success rate of RF ablation in the treatment of AF varies depending on the type and duration of AF (ie, paroxysmal vs persistent), structural remodeling of the heart, co-morbidities and the technique of the cardiac electrophysiologist, but it usually ranges from 60-80% over 1-2 years of follow-up.
To study and predict the successful outcome of RF ablation is of great clinical importance. Moreover, the detection of predictive factors for successful outcome may alter the therapeutic strategy determining a subgroup of patients in the need of more invasive management.
详细描述
The study will include 150 patients scheduled to undergo pulmonary vein (PV) ablation because of non-responsive to medical therapy PAF. ECG recordings will be obtained during sinus rhythm before and after PV ablation with a 3 - channel digital recorder for 10 minutes, and digitized with a 16-bit accuracy at a sampling rate of 1000 Hz. The P wave will be analyzed using the Morlet wavelet. Other parameters to be analyzed include 12 lead surface ECG, the burden of main and secondary morphologies and echocardiographic indexes of left atrial mechanical function. Follow-up visits will be held in 3, 6 and 12 months after the ablation procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females
- •Age >18 years
- •Paroxysmal AF (PAF) scheduled to undergo pulmonary vein (PV) ablation
- •Singed written consent form
- •Patients who will comply with study procedures
排除标准
- •Age <18 years Permanent atrial fibrillation
- •Acute myocardial infraction, coronary artery bypass graft surgery or percutaneous transluminal coronary angioplasty within less than 2 months prior to ablation procedure
- •Life expectancy less than 12 months, according to investigator's judgment
- •Participation to other clinical trial
- •Patients who will not be compliant with study procedures
结局指标
主要结局
Number of Paroxysmal Atrial Fibrillation (PAF) relapse(s)
时间窗: 12 months
Primary end point is one or more PAF relapse(s) during a period of 12 months after the ablation procedure.
次要结局
- Number of Adverse Events(12 months)