NCT06310707

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Arrythmia
• Syncope

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-11-09
• Primary completion: 2025-07-10
• Completion: 2025-07-10
• First posted: 2024-03-15
• Last updated: 2025-12-08

Locations

2 sites across 2 countries: France, Germany

Regulatory

• FDA-regulated device study