Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 6
- 主要终点
- Device Monitoring Using Only One ECG Lead
研究概览
简要总结
The purpose of this study is to conduct an observational investigation of a novel care path used to manage emergency department (ED) presenting syncope patients on an outpatient basis.
详细描述
OBJECTIVES To conduct a prospective observational study assessing a unique outpatient care model in which syncope patients are provided with, and trained to use, a wearable defibrillator prior to discharge from the emergency department (ED). Observational data will be collected to assess the logistics of equipping patients with the device and providing training in the ED, and the ability of patients to receive follow-up care on an outpatient basis. In addition, data will be collected to confirm that the device meets expected safety. The experience gained from this stage of the study will be used to guide future studies of device's functionality enhancements and definitive device safety and efficacy.
STUDY POPULATION Participants will be patients presenting to the ED following a syncope event which has been defined as cardiac, or potentially cardiac, i.e. undiagnosed in nature.
INTERVENTION A wearable defibrillator optimized for short-term ambulatory use with adhesive electrodes will be prescribed for up to 14 days of use following emergency department discharge or until the physician responsible for the subject's care defines an alternative treatment plan.
STUDY DESIGN This is a single-arm feasibility study.
STUDY SIZE The study will enroll a minimum of 50 and a maximum of 80 subjects. A maximum of 20 centers will be used for enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Experienced a syncopal event within the past 48 hours
- •Either one of the following profiles(A or B) apply:
- •A. ED workup indicates that the patient may have experienced syncope that is cardiac in nature (any one or more of the following apply:
- •History or diagnosis of structural heart disease
- •History of cardiovascular disease
- •Palpitations experienced pre-syncope
- •Major ECG abnormalities:
- •QRS-duration greater than 140 ms
- •PR-interval greater than 200 ms
- •Non-specific repolarization abnormality
- •Syncope experienced without any warning
- •Syncope experienced while supine
- •Syncope during exercise B. ED workup does not indicate a clear cause of the syncopal event
排除标准
- •Clear diagnosis of non-cardiac syncope (e.g. orthostatic hypotensive syncope, vasovagal syncope, carotid sinus syncope, situational fainting)
- •An active implantable cardioverter-defibrillator (ICD)
- •An active unipolar pacemaker
- •Significant risk or suffering a cardiovascular event such as:
- •Symptoms of New York Heart Association (NYHA) class III or IV heart failure
- •ED diagnosis of acute coronary syndrome
- •Having required resuscitation in response to the index syncopal event
- •Advanced directive prohibiting resuscitation (DNR)
- •Physical or mental conditions preventing subjects from interacting with or wearing the device as determined by the investigating physician.
- •Bandages or other clinical condition preventing SWD 1000 use
- •Injuries or other conditions beyond simple syncope that require hospitalization
- •Travel out of town during the study participation period that prevents the field service representative from visiting the subject daily
- •Unable or unwilling to provide written informed consent
结局指标
主要结局
Device Monitoring Using Only One ECG Lead
时间窗: enrollment to 30 days
% time that the device is monitoring using only one lead due to noise detected on the other lead
ER or Hospitalization
时间窗: enrollment to 30 days
Followup care for syncope - returned to ER or admitted to hospital
Device Unable to Monitor Due to ECG Noise
时间窗: enrollment to 30 days
% time the device detected noise on both leads at the same time.
Followup Care Visits
时间窗: enrollment to 30 days
Followup care for syncope - outpatient medical care visits
次要结局
- Duration of Use(enrollment to 30 days)