Electra-1; Elective Cardioversion of Atrial Fibrillation at Home by Advanced Practice Providers; A Feasibility Study in Dutch Emergency Medical Service
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- completion of cardioversion to sinus rhythm
研究概览
简要总结
The goal of this pilot, non-controlled, non-randomised, single centre, prospective intervention feasibility study is to assess the feasibility of a home DC-ECV in the treatment of recurrent symptomatic AF performed by APP in 25 patients.
The main question[s] it aims to answer are:
Primary objective:
In this prospective intervention feasibility study, in 25 patients the primary endpoint is completion of cardioversion to sinus rhythm. (% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation).
Feasibility endpoints are ; (a) evaluation of enrolment of participants, (b) evaluation and refinement of data and outcome collection procedures, (c) evaluation of logistics, (d) evaluation of the appropriateness of the intervention and research procedures to manage and implement the intervention, and (e) preliminary evaluation of participant responses to the intervention.
Secondary objectives:
Safety endpoint:
Complications immediately during and one hour after cardioversion (e.g. arrhythmias, changes in the electrocardiogram, hypotension related to sedation and/or vasodilation or skin irritation).
A composite of major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 24 hours MACCE occurring during 6 weeks follow-up; any hospitalisation and all-cause mortality during 6 weeks follow-up; number (%) of patients in sinus rhythm at 1 hour in the post-shock observation period; idem at the end of 6 weeks follow-up; inventory of all interventions in the study related to cost-of-care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent.
- •Age 18 -75 year subjects, able to understand the provided information and sign an informed consent.
- •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)).
- •Weight more than 50 kilograms.
- •Successful hospital DC-ECV for a previous episode of AF performed under propofol sedation.
- •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.
- •BMI < 35 kg/m
- •Fasting status: at least 6 hours for food, and 2 hours for fluids.
排除标准
- •1. Patients over 75 years old and younger than 18 years.
- •Patients wearing pacemaker or implantable cardioverter-defibrillator.
- •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.
研究组 & 干预措施
intervention arm
there is only one intervention arm
干预措施: Duble current electro cardioversion (Procedure)
结局指标
主要结局
completion of cardioversion to sinus rhythm
时间窗: within 60 minutes after cardioversion
% of study patients with a recurrence of AF in whom a home cardioversion is performed, i.e. to whom at least one DC shock was administered while the patient was under sedation
次要结局
- Incidence of treatment-emergent adverse events (Safety endpoint a)(up to 1 hour after treatment)
- Incidence of treatment-emergent adverse events (Safety endpoint b)(during 6 weeks follow-up)
研究者
Risco van Vliet
Principal Investigator
RAV Brabant MWN