Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study

NCT02188147 | Completed Results

• 1 other identifier: 90D0119
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 6

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.

Conditions

Syncope

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Device Unable to Monitor Due to ECG Noise

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

  enrollment to 30 days

• 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

• Followup Care Visits

  Followup care for syncope - outpatient medical care visits

  enrollment to 30 days

• ER or Hospitalization

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

  enrollment to 30 days

Secondary Outcomes (1)

• Duration of Use

  enrollment to 30 days

Study Arms (1)

SWD 1000

EXPERIMENTAL

Short Term Wearable Defibrillator

Device: Short Term Wearable Defibrillator

Interventions

Short Term Wearable Defibrillator DEVICE

Short-term Wearable Defibrillator (SWD 1000)

SWD 1000

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (6)

Unknown Facility

Danbury, Connecticut, United States

Location

Unknown Facility

Jacksonville, Florida, United States

Location

Unknown Facility

Minneapolis, Minnesota, United States

Location

Unknown Facility

Saint Paul, Minnesota, United States

Location

Unknown Facility

Staten Island, New York, United States

Location

Unknown Facility

Cincinnati, Ohio, United States

Location

MeSH Terms

Conditions

Syncope; Death, Sudden, Cardiac; Heart Arrest; Emergencies

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Disease Attributes

Results Point of Contact

• Title: Vice President Medical Affairs
• Organization: ZOLL

stevens@zoll.com

412-968-3333

Study Officials

• Steve Szymkiewicz, MD

  Zoll Medical Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 11, 2014
• Study Start: August 1, 2014
• Primary Completion: April 1, 2020
• Study Completion: April 15, 2020
• Last Updated: February 21, 2023
• Results First Posted: February 21, 2023

Record last verified: 2023-01

Locations

US (6)