Change in Inflammatory State in Patients Undergoing Transcatheter Ablation of Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment.
研究概览
简要总结
It is a non-pharmacological (biological), spontaneous observational study. The main objective is to evaluate the correlation between inflammation markers and local adiposity, clinical risk factors and their possible variation following an AF ablation procedure
详细描述
The study includes the execution of a sample for each time point for the evaluation of inflammation and fibrosis markers identified so far in the literature, such as Interleukin 6, N-terminal propeptide of procollagen type 1 (P1NP), chitinase-3-like protein 1 (YKL-40), tumor necrosis factor (TNF-alpha), GlycA, proprotein convertase subtilisin/kexin type 9 and omega-3 fatty acids.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Paroxysmal or persistent AF;
- •Patients undergoing ESC/ERAH(European Society of Cardiology/European Heart Rhythm Association) approved catheter ablation procedures;
- •Aged between 18 and 85 years;
- •Ability to provide informed consent for study participation.
排除标准
- •Age > 85 years or < 18 years;
- •Presence of left auricular thrombosis on pre-procedural transesophageal echocardiogram;
- •NYHA functional class IV;
- •Left ventricular ejection fraction <30%;
- •Myocardial infarction or unstable angina or recent coronary artery bypass graft (<6 months);
- •Significant co-morbidity, such as cancer, severe renal failure requiring dialysis, severe obstructive pulmonary disease, cirrhosis, with a life expectancy of less than 12 months;
- •Presence of contraindications to the procedure;
- •Inability to provide informed consent for study participation.
结局指标
主要结局
Prevalence of subjects with AF undergoing ablation who have a reduction of inflammatory burden following treatment.
时间窗: One year
Outcome measured through biochemical analyzes conducted on the patient: interleukin 6 (pg/ml), procollagen type 1 N-terminal propeptide (µg/l), chitinase-3-like protein 1(ng/ml), tumor necrosis factor -TNF-alpha - (pg/ml), GlycA (mmol/mol).
次要结局
- Prevalence of subjects with AF undergoing ablation who show improvement in clinical terms and in the arrhythmia recurrence rate.(One year)
- Relationship between the degree of inflammation and atrial fibrosis and the degree of atrial fibrosis detected by electroanatomical mapping.(One year)
研究者
Stefano Carugo
Director of the Department of Cardio-Thoracic-Vascular Diseases
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico