Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study

Syncope Clinical Trial

— ASAP  

Official title:

Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study Protocol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188147
• Other study ID #: 90D0119
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Est. completion date: April 15, 2020

Study information

• Verified date: January 2023
• Source: Zoll Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 15, 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syncope

Intervention

Device:
• Short Term Wearable Defibrillator
Short-term Wearable Defibrillator (SWD 1000)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device Unable to Monitor Due to ECG Noise	% time the device detected noise on both leads at the same time.	enrollment to 30 days
Primary	Device Monitoring Using Only One ECG Lead	% time that the device is monitoring using only one lead due to noise detected on the other lead	enrollment to 30 days
Primary	Followup Care Visits	Followup care for syncope - outpatient medical care visits	enrollment to 30 days
Primary	ER or Hospitalization	Followup care for syncope - returned to ER or admitted to hospital	enrollment to 30 days
Secondary	Duration of Use	Average time the SWD 1000 was used by participants	enrollment to 30 days