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

NCT06310707 | Terminated FDA Device

• 3 other identifiers: EU RCT: ePatch vs 24h Holter2022-A02338-35EA4/071/23
• Study Type: interventional
• Target: 55
• Locations: 2 countries
• Sites: 2

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.

Conditions

Arrythmia; Syncope

Keywords

Clinically Actionable Arrhythmia; Symptoms of syncope

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (2)

ePatch® Extended Wear Holter (EWH) Arm

EXPERIMENTAL

Participants will undergo long-term continuous ambulatory ECG recording of 7-day duration

Device: ePatch ® Extended Wear Holter (EWH)

Standard of Care

NO INTERVENTION

Participants will undergo 24 hours of continuous ECG recording.

Interventions

ePatch ® Extended Wear Holter (EWH) DEVICE

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

ePatch® Extended Wear Holter (EWH) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (2)

Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel

Bron, 69677 Cedex, France

Location

Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin

Berlin, D-12203, Germany

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Syncope

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: March 15, 2024
• Study Start: November 9, 2023
• Primary Completion: July 10, 2025
• Study Completion: July 10, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); DE (1)