ArrythmiaNCT06310707
Arrhythmia Identification in Syncope Patients: ePatch® Versus 24h Holter
A study testing ePatch ® Extended Wear Holter (EWH) in people with Arrythmia and Syncope, run by Philips Clinical & Medical Affairs Global at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- ePatch ® Extended Wear Holter (EWH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 9 Nov 2023to 10 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
France1 site
Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel
Bron, 69677 Cedex
Germany1 site
Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin
Berlin, D-12203
About this study
Official title: 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.
Read the 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.
- Being tested
- ePatch ® Extended Wear Holter (EWH)
- Keywords
- Clinically Actionable Arrhythmia, Symptoms of syncope
- Medical subject headings
- Arrhythmias, Cardiac, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| ePatch® Extended Wear Holter (EWH) Arm | Experimental | Participants will undergo long-term continuous ambulatory ECG recording of 7-day duration Receives: Device: ePatch ® Extended Wear Holter (EWH) |
| Standard of Care | No intervention | Participants will undergo 24 hours of continuous ECG recording. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 7 days
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 7 days
Time Holter is worn/ removed
Compare time Holter is worn/removed
- Assess via diary
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start9 Nov 2023
- Primary completion10 Jul 2025
- Study completion10 Jul 2025
Why it stopped: 1\. Slow Enrollment. 2. Issues regarding reimbursement of product
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrythmiaStudies of the same condition, open and under way.
- More trials run by Philips Clinical & Medical Affairs GlobalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06310707
- Sponsor's protocol ID
- EU RCT: ePatch vs 24h Holter
- Other IDs
- 2022-A02338-35, EA4/071/23
- Status last verified
- Dec 2025
- First submitted
- 29 Nov 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study to Identify Clinically Actionable Arrhythmia Using the ePatch® Extended Wear Holter vs. Standard Wear Holter
- ClinicalTrials.gov ID
- NCT06310707
- Acronym / sponsor ID
- EU RCT: ePatch vs 24h Holter
- Keywords
- Clinically Actionable Arrhythmia, Symptoms of syncope
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 1\. Slow Enrollment. 2. Issues regarding reimbursement of product
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2023 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 10 Jul 2025 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| ePatch® Extended Wear Holter (EWH) Arm | Experimental | Device: ePatch ® Extended Wear Holter (EWH)Participants will undergo long-term continuous ambulatory ECG recording of 7-day duration |
| Standard of Care | No intervention | –Participants will undergo 24 hours of continuous ECG recording. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | ePatch® Extended Wear Holter (EWH) Arm |
Primary outcome
Diagnostic yield (frequency) of clinically actionable arrythmia
Time frame: Up to 7 days
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).
7 secondary outcomes
Number of Atrial Fibrillation (AF) diagnoses > 30 seconds
Time frame: Up to 7 days
Occurrence of symptomatic events
Time frame: Up to 7 days
Number of Clinically actionable arrhythmia
Time frame: Up to 7 days
Patient Quality of Life as measured by EQ-5D-5L
Time frame: Up to 7 days
Patient Quality of Life as measured by Patient Experience Survey
Time frame: Up to 7 days
Cost related to cardiac monitoring
Time frame: Up to 7 days
Time Holter is worn/ removed
Time frame: Up to 7 days
Results and safety
The study was stopped early (reason given: 1\. Slow Enrollment. 2. Issues regarding reimbursement of product). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Arrythmia
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Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
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RecruitingObservational study
Southeast Asian Brugada Syndrome Cohort
Brugada Syndrome
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
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Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ePatch ® Extended Wear Holter (EWH) in people with Arrythmia and Syncope, run by Philips Clinical & Medical Affairs Global at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 1\. Slow Enrollment. 2. Issues regarding reimbursement of product). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (frequency) of clinically actionable arrythmia (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.