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

Syncope Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06310707
• Other study ID #: EU RCT: ePatch vs 24h Holter
• Secondary ID: 2022-A02338-35EA
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2023
• Est. completion date: August 2025

Study information

• Verified date: March 2024
• Source: Philips Clinical & Medical Affairs Global
• Contact: Purvee Parikh
• Phone: +1 619-929-6310
• Email: purvee.parikh[@]philips.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 128
• Est. completion date: August 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arrhythmias, Cardiac
• Arrythmia
• Syncope

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel	Bron
Germany	Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Philips Clinical & Medical Affairs Global

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Time Holter is worn/ removed	Compare time Holter is worn/removed; - Assess via diary	Up to 7 days