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

Last updated: December 1, 2025
Sponsor: Philips Clinical & Medical Affairs Global
Overall Status: Terminated

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Circulation Disorders

Dizzy/fainting Spells

Treatment

ePatch ® Extended Wear Holter (EWH)

Clinical Study ID

NCT06310707
EU RCT: ePatch vs 24h Holter
2022-A02338-35
EA4/071/23
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 willingand able to be compliant with the protocol, including the follow-up visit(s)

Exclusion

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 Design

Total Participants: 55
Treatment Group(s): 1
Primary Treatment: ePatch ® Extended Wear Holter (EWH)
Phase:
Study Start date:
November 09, 2023
Estimated Completion Date:
July 10, 2025

Study 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.

Connect with a study center

  • Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel

    Bron, 69677 Cedex
    France

    Site Not Available

  • Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel

    Bron 3029931, 69677 Cedex
    France

    Site Not Available

  • Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin

    Berlin, D-12203
    Germany

    Site Not Available

  • Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin

    Berlin 2950159, D-12203
    Germany

    Site Not Available

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