NL-OMON56551招募中不适用
Elective cardioversion of atrial fibrillation at home by advanced practice providers; A feasibility study in Dutch emergency medical service. - ELECTRA-1
Jeroen Bosch ziekenhuis0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 25
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 99（—）
入选标准
- •1. 1. Signed informed consent 2. Age 18 -75 year subjects, able to understand
- •the provided information and sign an informed consent 3. Need for direct
- •current electrical cardioversion (DC-ECV) for correction of recurrent
- •symptomatic AF (according to the guidelines of the American College of
- •Cardiology/American Heart Association/European Society of Cardiology
- •(ACC/AHA/ESC)). 4. Weight more than 50 kilograms 5. Successful hospital DC-ECV
- •for a previous episode of AF performed under propofol sedation 6. Target range
- •of international normalized ratio (INR) above 2.0, when on vitamin K
- •antagonists, or use of novel oral anticoagulant, stable for 3 weeks 7. ASA 2 8.
- •BMI < 35 kg/m2
排除标准
- •1. Patients over 75 years old and younger than 18 years 2. Patients wearing
- •pacemaker or implantable cardioverter-defibrillator. 3. Patients with
- •(cardiovascular): * sick sinus syndrome, ventricular pre-excitation, Brugada
- •syndrome or bundle branch block * severe ischemic or valvular heart disease *
- •known second or third degree atrioventricular block normal sinus rhythm * heart
- •failure NYHA III or IV, known LVEF < 35%, or cor pulmonale * transient and
- •reversible cause of AF, e.g. in setting of fever and hyperthyroidism 4.
- •Patients with severe co-morbidities: a. liver disease b. kidney impairment
- •(eGFR <= 30 according to formula MDRD) c. pulmonary dysfunction (FEV1 /VC <75%
- •gold classification) d. active malignancy e. connective tissue disease f.
- •inflammatory disease such as peri-myocarditis/endocarditis 5. Life expectancy
- •less than 1 year 6. Patients with ventricular tachycardia or supraventricular
- •arrhythmias 7. Patients with slow ventricular rate (< 55/min), bifascicular
- •block 8. Contraindications to a sedation 9. Patients lacking family care at
- •home 10. Pregnancy 11. ASA 3 & 4 12. BMI > 35 kg/m2
研究者
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