Cardiovascular Medicine Department of Second Affiliated Hospital of Jiaxing University
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Postoperative heart-related complications
研究概览
简要总结
Patients with hyperthyroidism or hypothyroidism are often combined with atrial fibrillation, but after the stabilization of thyroid hormone levels after treatment, the patients' atrial fibrillation still persists. Radiofrequency ablation of the atrial fibrillation as one of the treatment options for atrial fibrillation has been widely used in the clinic, and has significant efficacy in maintaining sinus rhythm, improving cardiac function, and improving the prognosis of patients. However, there is a lack of clinical monitoring data on radiofrequency ablation of atrial fibrillation in patients who have combined thyroid dysfunction and have stabilized their thyroid hormone levels after treatment.
详细描述
In patients recommended by guidelines for atrial catheter radiofrequency ablation of atrial fibrillation, catheter radiofrequency ablation was performed after exclusion of contraindications, and was observed and compared between patients with comorbid pre-existing thyroid hormone disorders and patients without comorbid atrial fibrillation after radiofrequency ablation:1: time to sexual rhythm maintenance: incidence of cardiac-related complications and incidence of noncardiac-related complications within 3 months and 1 year,2: walking distance on a six-minute walk test within 3 months,1 year, comparison of percent left ventricular ejection fraction, and comparison of left ventricular diastolic diameter at the time 3 months,1 year,.To comprehensively assess the efficacy and safety of catheterized radiofrequency ablation of atrial fibrillation in patients with comorbidities of prior thyroid hormone disorders.
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation （Class I Recommendation）
排除标准
- •Atrial Fibrillation Requiring Catheterized Radiofrequency Ablation Class I Recommendation With Coexisting Contraindications
结局指标
主要结局
Postoperative heart-related complications
时间窗: 3 month and 1year after cardiac radiofrequency ablation
Cardiac perforation/cardiac tamponade Coronary artery stenosis/occlusion Pericarditis Atrial stiffness syndrome Coronary artery air embolism Pseudoaneurysm Severe pulmonary stenosis
Non-Cardiac Related Complications
时间窗: 3 month and 1year after cardiac radiofrequency ablation
Neurological Complications Asymptomatic cerebral embolism TIA Perioperative stroke Permanent phrenic nerve injury Digestive Complications Esophageal Injury Gastric Hyperdynamics Atrioesophageal Fistula Vascular Complications Hematoma Arteriovenous fistula Pseudoaneurysm Severe pulmonary stenosis
Recurrence of atrial fibrillation Recurrence of atrial fibrillation Recurrence of atrial fibrillation Recurrence of atrial fibrillation Recurrence of atrial fibrillation Recurrence of atrial fibrillation Recurrence of atrial fibrillation
时间窗: 3 month and 1year after cardiac radiofrequency ablation
Inability to maintain sinus rhythm, recurrent atrial fibrillation or atrial flutter
次要结局
- 6-minute walk test(3 month and 1year after cardiac radiofrequency ablation)
- Left Atrial Internal Diameter(3 month and 1year after cardiac radiofrequency ablation)
- LVEF%(3 month and 1year after cardiac radiofrequency ablation)