Arrythmia, Syncope
Conditions
Keywords
Clinically Actionable Arrhythmia, Symptoms of syncope
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.
Interventions
DEVICEePatch ® Extended Wear Holter (EWH)
Diagnostic Test: Extended ECG investigation • An ambulatory ECG recordings with a duration of 7 days using Philips ePatch (https://www.myheartmonitor.com/device/epatch/) will be applied
Sponsors
Philips Clinical & Medical Affairs Global
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Multi-center, prospective, randomized, unblinded, two-arm study, to include approximately 128 subjects treated with the ePatch Extended Wear Holter (worn for 7 days) and approximately 128 subjects treated with a Standard Wear Holter (worn for 24 hours). Randomization will be balanced for gender.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years old 2. Recommended for ambulatory cardiac Holter monitoring due to symptoms of syncope 3. Able to comply with continuous ECG monitoring for up to 7 days 4. Able and willing to replace the Patch electrode at home 5. 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
1. Patient with chronic Atrial Fibrillation (AF) 2. Patient with implanted pacemaker/defibrillator 3. Patient with known allergy to adhesive materials and/or hydrogel 4. Patient with broken, damaged, or irritated skin where ECG patch will be placed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic yield (frequency) of clinically actionable arrythmia | 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
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of symptomatic events | Up to 7 days | Occurrence of symptomatic events in 7 days of monitoring using the ePatch Extended Wear Holter vs. Standard Wear Holter (24 hours). |
| Number of Clinically actionable arrhythmia | Up to 7 days | Clinically actionable arrhythmia yield vs days of data collected * Analysis for all patients * Analysis for patients with sporadic symptoms (less than one per day) |
| Patient Quality of Life as measured by EQ-5D-5L | Up to 7 days | Patient Quality of Life will be measured using the EQ-5D-5L at 24-hours (Standard Wear Holter and ePatch) and at end of service (ePatch arm only, at 7 days). The EQ-5D-5L stands for EuroQol, 5 dimensions, 5 levels. EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). Higher scores mean a worse outcome. |
| Number of Atrial Fibrillation (AF) diagnoses > 30 seconds | Up to 7 days | Number of Atrial Fibrillation (AF) diagnoses \> 30 seconds with 7 days of monitoring using the ePatch Extended Wear Holter vs. Standard Wear Holter (24 hours). |
| Cost related to cardiac monitoring | Up to 7 days | \- Compare clinical workflow costs from 7 days of cardiac monitoring using the ePatch Extended Wear Holter vs. 24 hours of cardiac monitoring with Standard Wear Holter. |
| Time Holter is worn/ removed | Up to 7 days | Compare time Holter is worn/removed \- Assess via diary |
| Patient Quality of Life as measured by Patient Experience Survey | Up to 7 days | Patient Quality of Life will be measured using survey data at 24-hours (Standard Wear Holter and ePatch) and at end of service (7 days for ePatch arm) Each question in the Patient Experience Survey has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). Higher scores mean a worse outcome. |
Countries
France, Germany
Outcome results
None listed