Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study

Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study Protocol

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02188147

Acronym

ASAP

Enrollment

Registered

2014-07-11

Start date

2014-08-31

Completion date

2020-04-15

Last updated

2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Syncope

Keywords

Syncope, Sudden Cardiac Arrest, Sudden Cardiac Death, Cardiac Arrest, Emergency Service, Emergency Department, Ambulatory Electrocardiography, Holter, Holter Electrocardiography, Holter Monitoring

Brief summary

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.

Detailed description

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.

Interventions

DEVICEShort Term Wearable Defibrillator

Short-term Wearable Defibrillator (SWD 1000)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Age≥18 2. Experienced a syncopal event within the past 48 hours 3. 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 * Age ≥ 40 * 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

Exclusion criteria

1. Clear diagnosis of non-cardiac syncope (e.g. orthostatic hypotensive syncope, vasovagal syncope, carotid sinus syncope, situational fainting) 2. An active implantable cardioverter-defibrillator (ICD) 3. An active unipolar pacemaker 4. 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) 6\. Physical or mental conditions preventing subjects from interacting with or wearing the device as determined by the investigating physician. 7\. Bandages or other clinical condition preventing SWD 1000 use 8. Injuries or other conditions beyond simple syncope that require hospitalization 9. Travel out of town during the study participation period that prevents the field service representative from visiting the subject daily 10. Unable or unwilling to provide written informed consent

Design outcomes

Primary

Measure	Time frame	Description
Device Unable to Monitor Due to ECG Noise	enrollment to 30 days	% time the device detected noise on both leads at the same time.
Device Monitoring Using Only One ECG Lead	enrollment to 30 days	% time that the device is monitoring using only one lead due to noise detected on the other lead
Followup Care Visits	enrollment to 30 days	Followup care for syncope - outpatient medical care visits
ER or Hospitalization	enrollment to 30 days	Followup care for syncope - returned to ER or admitted to hospital

Secondary

Measure	Time frame	Description
Duration of Use	enrollment to 30 days	Average time the SWD 1000 was used by participants

Countries

United States

Participant flow

Participants by arm

Arm	Count
SWD 1000 Subjects assigned to use a Short Term Wearable Defibrillator (SWD 1000)	39
Total	39

Baseline characteristics

Characteristic	SWD 1000
Active pacemaker	1 Participants
Age, Continuous	44.4 years STANDARD_DEVIATION 17.8
Blood pressure Diastolic	76 mm Hg STANDARD_DEVIATION 13
Blood pressure Systolic	127 mm Hg STANDARD_DEVIATION 18
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	39 Participants
Family history of sudden death	6 Participants
Heart rate	76 beats per minute STANDARD_DEVIATION 15
Height	67.5 inches STANDARD_DEVIATION 3.8
Past history of atrial fibrillation	2 Participants
Past history of diabetes	9 Participants
Past history of heart failure	3 Participants
Past history of myocardial infarction	3 Participants
Past history of renal failure	1 Participants
Prior syncope	29 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	39 Participants
Race (NIH/OMB) White	0 Participants
Respiration rate	16.4 breaths per minute STANDARD_DEVIATION 2.5
Sex: Female, Male Female	15 Participants
Sex: Female, Male Male	24 Participants
Weight	185.2 pounds STANDARD_DEVIATION 51.6

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 39
other Total, other adverse events	13 / 39
serious Total, serious adverse events	0 / 39