Arrhythmia Identification in Syncope Patients: ePatch® Versus 24h Holter

A Randomized Controlled Study to Identify Clinically Actionable Arrhythmia Using the ePatch® Extended Wear Holter vs. Standard Wear Holter

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.

Study Overview

• Status: Terminated
• Conditions: Syncope; Arrythmia
• Intervention / Treatment: Device: ePatch ® Extended Wear Holter (EWH)

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 Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France, 69677 Cedex
    • Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel
• Germany
  • Berlin, Germany, D-12203
    • Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ePatch® Extended Wear Holter (EWH) Arm; Participants will undergo long-term continuous ambulatory ECG recording of 7-day duration	Device: ePatch ® 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
No Intervention: Standard of Care; Participants will undergo 24 hours of continuous ECG recording.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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)	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.	Up to 7 days
Patient Quality of Life as measured by Patient Experience Survey	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.	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.	Up to 7 days
Time Holter is worn/ removed	Compare time Holter is worn/removed - Assess via diary	Up to 7 days

Collaborators and Investigators

• Sponsor: Philips Clinical & Medical Affairs Global

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2023
• Primary Completion (Actual): July 10, 2025
• Study Completion (Actual): July 10, 2025

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: March 6, 2024
• First Posted (Actual): March 15, 2024

Study Record Updates

• Last Update Posted (Actual): December 8, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Clinically Actionable Arrhythmia; Symptoms of syncope
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Neurobehavioral Manifestations; Consciousness Disorders; Unconsciousness; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Arrhythmias, Cardiac; Syncope
• Other Study ID Numbers: EU RCT: ePatch vs 24h Holter; 2022-A02338-35 (Other Identifier: ANSM, French competent authority); EA4/071/23 (Other Identifier: German Ethics Committee_Charité Universitätsmedizin Berlin)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes