NCT02188147

Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study

Ambulatory Post-Syncope Arrhythmia Protection Feasibility Study Protocol

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Zoll Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Syncope

Interventions

Type	Name	Description
DEVICE	Short Term Wearable Defibrillator	Short-term Wearable Defibrillator (SWD 1000)

Timeline

• Start date: 2014-08-01
• Primary completion: 2020-04-01
• Completion: 2020-04-15
• First posted: 2014-07-11
• Last updated: 2023-02-21
• Results posted: 2023-02-21

Locations

6 sites across 1 country: United States