Study of ECG-derived Atrial Fibrillatory Rate for Prediction of the Outcome of Cardioversion of Short Duration Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Region Skane
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Documentation of atrial fibrillation by ECG during follow up period after cardioversion
研究概览
简要总结
The study is aimed at testing the hypothesis whether atrial fibrillary rate (AFR), as a measure of atrial electrical remodeling assessed from surface ECG, is predictive of sinus rhythm maintenance after electrical cardioversion.
Earlier studies performed in a retrospective fashion suggested that high AFR exceeding 350-360 fibrillations per minute is an independent predictor of AF relapse after cardioversion, particularly in patients with duration of AF episode not exceeding 30 days, however this hypothesis has not been tested in a prospective study.
CASAF is an observational study that will enroll patients with short duration (< 30 days) AF admitted for electrical cardioversion. Admission ECG will be extracted in a digital format and processed off-line for estimation of AFR. AF relapse will be assessed during 6-weeks long follow-up period during which ECG control will be scheduled at week 1 and 6.
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
- •Recurrent AF verified by at least one ECG recording prior to the index admission
- •Known onset of symptoms within 30 days from index admission.
- •Sinus rhythm ECG within 30 days prior to the index admission If onset of symptoms is unknown.
- •If duration of the present AF episode >48 hours then thromboembolic risk should be minimized by either verifying that the patient is adequately anticoagulated according to the hospital routine or TEE performed to verify the lack of contraindications for electrical cardioversion.
- •Echocardiography at any time since first onset of AF to verify the lack of significant valvular disease.
- •Age older than 18 years.
排除标准
- •AF due to reversible cause or significant valvular heart disease
- •Treatment with class I or III antiarrhythmic drugs within five half-lives of their elimination period. No amiodarone treatment within six months before admission
- •Prior ablation of AF
- •Unability to verify onset of symptoms within 30 days prior to the index admission
结局指标
主要结局
Documentation of atrial fibrillation by ECG during follow up period after cardioversion
时间窗: 6 weeks
Primary outcome measure in the CASAF study is the number of patients who had relapse of atrial fibrillation during follow up. Primary analysis will be based on assessment the value of the ECG-derived atrial fibrillary rate \< vs \>= 350 f.p.m. for prediction of atrial fibrillation relapse during follow up
次要结局
未报告次要终点