A Randomized Controlled Study to Identify Clinically Actionable Arrhythmia Using the ePatch® Extended Wear Holter vs. Standard Wear Holter
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 55
- Locations
- 4
- Primary Endpoint
- Diagnostic yield (frequency) of clinically actionable arrythmia
Study Overview
Brief Summary
This study is a Multi-center, prospective, randomized, unblinded, two-arm study to assess if 7-days of cardiac monitoring using the ePatch Holter results in identification of more clinically actionable arrythmia for patients with symptoms of syncope than standard 24 hour Holter monitoring.
Detailed Description
This study is a multi-center, prospective, randomized, unblinded, two-arm study to assess if 7-days of cardiac monitoring using the ePatch Holter results in identification of more clinically actionable arrythmia for patients with symptoms of syncope than standard 24 hour Holter monitoring. Approximately 256 adult subjects with symptoms of syncope will be randomized 1:1 to wear either the Philips ePatch Extended Wear Holter (7 day) or Standard Wear Holter (24 hours). Randomization will be balanced for gender.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥ 18 years old
- •Recommended for ambulatory cardiac Holter monitoring due to symptoms of syncope
- •Able to comply with continuous ECG monitoring for up to 7 days
- •Able and willing to replace the Patch electrode at home
- •Capable of providing voluntary informed consent and mentally and physically willing and able to be compliant with the protocol, including the follow-up visit(s)
Exclusion Criteria
- •Patient with chronic Atrial Fibrillation (AF)
- •Patient with implanted pacemaker/defibrillator
- •Patient with known allergy to adhesive materials and/or hydrogel
- •Patient with broken, damaged, or irritated skin where ECG patch will be placed
Arms & Interventions
ePatch® Extended Wear Holter (EWH) Arm
Participants will undergo long-term continuous ambulatory ECG recording of 7-day duration
Intervention: ePatch ® Extended Wear Holter (EWH) (Device)
Standard of Care
Participants will undergo 24 hours of continuous ECG recording.
Outcomes
Primary Outcomes
Diagnostic yield (frequency) of clinically actionable arrythmia
Time Frame: Up to 7 days
In patients indicated for cardiac monitoring due to syncope, show that the diagnostic yield (frequency) of clinically actionable arrythmia with 7 days of monitoring using the ePatch Extended Wear Holter is superior to what would be seen with the Standard Wear Holter (24 hours).
Secondary Outcomes
- Number of Clinically actionable arrhythmia(Up to 7 days)
- Patient Quality of Life as measured by EQ-5D-5L(Up to 7 days)
- Patient Quality of Life as measured by Patient Experience Survey(Up to 7 days)
- Number of Atrial Fibrillation (AF) diagnoses > 30 seconds(Up to 7 days)
- Occurrence of symptomatic events(Up to 7 days)
- Cost related to cardiac monitoring(Up to 7 days)
- Time Holter is worn/ removed(Up to 7 days)
- Number of Atrial Fibrillation (AF) diagnoses > 30 seconds(Up to 7 days)
- Occurrence of symptomatic events(Up to 7 days)
- Number of Clinically actionable arrhythmia(Up to 7 days)
- Patient Quality of Life as measured by EQ-5D-5L(Up to 7 days)
- Patient Quality of Life as measured by Patient Experience Survey(Up to 7 days)
- Cost related to cardiac monitoring(Up to 7 days)
- Time Holter is worn/ removed(Up to 7 days)