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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
55
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
Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel
Bron, France
Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin
Berlin, Germany
Diagnostic yield (frequency) of clinically actionable arrythmia
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).
Time frame: Up to 7 days
Number of Atrial Fibrillation (AF) diagnoses > 30 seconds
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).
Time frame: Up to 7 days
Occurrence of symptomatic events
Occurrence of symptomatic events in 7 days of monitoring using the ePatch Extended Wear Holter vs. Standard Wear Holter (24 hours).
Time frame: Up to 7 days
Number of Clinically actionable arrhythmia
Clinically actionable arrhythmia yield vs days of data collected * Analysis for all patients * Analysis for patients with sporadic symptoms (less than one per day)
Time frame: Up to 7 days
Patient Quality of Life as measured by EQ-5D-5L
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.
Time frame: Up to 7 days
Patient Quality of Life as measured by Patient Experience Survey
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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.
Time frame: Up to 7 days
Cost related to cardiac monitoring
\- 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 frame: Up to 7 days
Time Holter is worn/ removed
Compare time Holter is worn/removed \- Assess via diary
Time frame: Up to 7 days