EUCTR2018-002103-33-FR进行中（未招募）1 期
Pulmonary vein isolation with versus without continued antiarrhythmic drug treatment in subjects with persistent atrial fibrillation: a prospective multi-centre randomized controlled clinical study (POWDER-AF2 study)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1. Patient with symptomatic persistent AF, resistant to ongoing or prior ADT (failed ADT)
- •Patients is considered to have persistent AF if the patient has suffered any prior AF episode =7 days (ESC 2016 guidelines).
- •2. Before PVI, there was at least one episode of persistent AF in the last year.
- •3. Signed Patient Informed Consent Form.
- •4. Age 18 years or older.
- •5. Able and willing to comply with all follow-up testing and requirements.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 160
排除标准
- •1. Patients not willing or not suited to take any class IC or III ADT.
- •2. Any prior AF episode =12 months, or any recurrence of AF <3 days after cardioversion.
- •3. Presence of structural heart disease on echo criteria:
- •severe valvular heart disease
- •LA size >50mm
- •LV ejection fraction <35% (except if suspected tachycardiomyopathy)
- •septal diameter >15mm
- •4. BMI >35
- •5. Recent (<3 months) CABG, myocardial infarction, CVA, uncontrolled heart failure or angina
- •6. Active illness or systemic infection or sepsis
- •7. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause
- •8. Awaiting cardiac transplantation or other cardiac surgery
- •9. Documented left atrial thrombus or atrial myxoma on imaging
- •10. History of blood clotting or bleeding abnormalities
- •11. Enrollment in any other study evaluating another device or drug
- •12. Women with childbearing potential
- •13. Life expectancy less than 12 months
- •14. Contraindication for catheter ablation (intramural thrombus, tumor or other abnormality that precludes catheter introduction, contraindication to anticoagulation therapy)
研究者
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