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Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study (ASAP)

Primary Purpose

Syncope

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Short Term Wearable Defibrillator

About this trial

This is an interventional basic science trial for Syncope focused on measuring Syncope, Sudden Cardiac Arrest, Sudden Cardiac Death, Cardiac Arrest, Emergency Service, Emergency Department, Ambulatory Electrocardiography, Holter, Holter Electrocardiography, Holter Monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age≥18
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
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:

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)

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SWD 1000

Arm Description

Short Term Wearable Defibrillator

Outcomes

Primary Outcome Measures

Device Unable to Monitor Due to ECG Noise

% time the device detected noise on both leads at the same time.

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

Followup Care Visits

Followup care for syncope - outpatient medical care visits

ER or Hospitalization

Followup care for syncope - returned to ER or admitted to hospital

Secondary Outcome Measures

Duration of Use

Average time the SWD 1000 was used by participants

Full Information

NCT ID

NCT02188147

First Posted

July 9, 2014

Last Updated

January 24, 2023

Sponsor

Zoll Medical Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02188147

Brief Title

Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study

Acronym

ASAP

Official Title

Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study Protocol

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

August 2014 (Actual)

Primary Completion Date

April 2020 (Actual)

Study Completion Date

April 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Zoll Medical Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Syncope

Keywords

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SWD 1000

Arm Type

Experimental

Arm Description

Short Term Wearable Defibrillator

Intervention Type

Device

Intervention Name(s)

Short Term Wearable Defibrillator

Intervention Description

Short-term Wearable Defibrillator (SWD 1000)

Primary Outcome Measure Information:

Title

Device Unable to Monitor Due to ECG Noise

Description

% time the device detected noise on both leads at the same time.

Time Frame

enrollment to 30 days

Title

Device Monitoring Using Only One ECG Lead

Description

% time that the device is monitoring using only one lead due to noise detected on the other lead

Time Frame

enrollment to 30 days

Title

Followup Care Visits

Description

Followup care for syncope - outpatient medical care visits

Time Frame

enrollment to 30 days

Title

ER or Hospitalization

Description

Followup care for syncope - returned to ER or admitted to hospital

Time Frame

enrollment to 30 days

Secondary Outcome Measure Information:

Title

Duration of Use

Description

Average time the SWD 1000 was used by participants

Time Frame

enrollment to 30 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age≥18 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 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: 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) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Steve Szymkiewicz, MD

Organizational Affiliation

Zoll Medical Corporation

Official's Role

Study Director

Facility Information:

City

Danbury

State/Province

Connecticut

Country

United States

City

Jacksonville

State/Province

Florida

Country

United States

City

Minneapolis

State/Province

Minnesota

Country

United States

City

Saint Paul

State/Province

Minnesota

Country

United States

City

Staten Island

State/Province

New York

Country

United States

City

Cincinnati

State/Province

Ohio

Country

United States

12. IPD Sharing Statement

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Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study

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