NL-OMON54021已完成不适用
Tailored vs Anatomical Ablation Strategy for Persistent AF - The Tailored-AF trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Patients 18 years of age or older candidates for a first AF ablation 2.
- •Symptomatic AF, refractory to at least one antiarrhythmic medication 3.
- •Persistent or long-standing persistent AF with documentation of (ECG, Holter,
- •physician*s letter): • AF duration of >= 3 months and <= 5 years or • 1 effective
- •cardioversion followed by AF recurrence lasting >= 3 months 4. Continuous
- •anticoagulation with warfarin (INR 2-3) or NOAC for > 4 weeks prior to ablation
- •5. Patients must be able and willing to provide written informed consent to
- •participate in the clinical trial 6. Maximum of 70% of patients (240 patients)
- •in persistent AF < 12 months (>30% of long-standing persistent AF >= 12 months)
排除标准
- •1. Paroxysmal and short-standing AF < 3 months 2. Long-standing persistent AF >
- •5 years 3. >= 2 previous ineffective cardioversion sessions in case of
- •undetermined AF duration 4. Severe obesity (BMI > 40) 5. Very dilated Left
- •Atrium (LA)(e.g. LA diameter > 55 mm and/or LA volume > 85 mL and/or LA surface
- •> 40 cm2) 6. Patients with AF secondary to an obvious reversible cause 7.
- •Inadequate anticoagulation as defined in the inclusion criteria 8. LA thrombus
- •on Transesophageal Echocardiography (TEE) prior to procedure 9.
- •Contraindications to anticoagulation (heparin, warfarin or NOAC) 10. Patients
- •who are or may potentially be pregnant 11. Previous surgical or catheter
- •ablation for AF 12. Any cardiac surgery within the past 2 months (60 days)
- •(includes PCI) 13. Myocardial infarction within the past 2 months (60 days) 14.
- •Previous AV valve surgery 15. History of blood clotting or bleeding
- •abnormalities 16. Documented thromboembolic event (including TIA) within the
- •past 12 months (365 days) 17. Rheumatic Heart Disease 18. Chronic severe Heart
- •Failure (NYHA functional class III and IV and/or LVEF < 25%) 19. Awaiting
- •cardiac transplantation or other cardiac surgery within the next 12 months (365
- •days) 20. Unstable angina within the past month 21. Acute illness or active
- •systemic infection or sepsis 22. AF secondary to electrolyte imbalance, thyroid
- •disease, or reversible or non-cardiac cause 23. Diagnosed atrial myxoma 24.
- •Significant severe pulmonary disease, (e.g. restrictive pulmonary disease,
- •constrictive or chronic obstructive pulmonary disease) or any other disease or
- •malfunction of the lungs or respiratory system that produces chronic symptoms
- •25. Significant congenital anomaly or medical problem that in the opinion of
- •the investigator would preclude enrollment 26. Enrollment in an investigational
- •study evaluating another device, biologic, or drug 27. Presence of intramural
- •thrombus, tumor or other abnormality or condition that precludes vascular
- •access, or manipulation of the catheter 28. Life expectancy or other disease
- •processes likely to limit survival to less than 12 months 29. Acute Covid-19
- •infection (fever and/or biological inflammatory syndrome, and positive test
- •documented)
研究者
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