Comparing ePatch Holter to standard Holter for detecting arrhythmias in syncope patients
A Randomized Controlled Study to Identify Clinically Actionable Arrhythmia Using the ePatch® Extended Wear Holter vs. Standard Wear Holter
This study tests whether a new 7-day heart monitor called the ePatch Holter can find dangerous heart rhythms better than the standard 24-hour monitor in patients who faint.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Philips Clinical & Medical Affairs Global Industry-sponsored |
| Locations | 2 sites (Bron and 1 other locations) |
| Trial ID | NCT06310707 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a 7-day cardiac monitoring device, the ePatch Holter, in identifying clinically actionable arrhythmias in patients experiencing syncope symptoms compared to the standard 24-hour Holter monitoring. It is a multi-center, prospective, randomized, unblinded study involving approximately 256 adult participants who will be randomly assigned to either monitoring method. The study aims to determine if extended monitoring can lead to better detection of arrhythmias that require clinical intervention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are recommended for ambulatory cardiac monitoring due to symptoms of syncope.
Not a fit: Patients with chronic atrial fibrillation, implanted pacemakers or defibrillators, or known allergies to adhesive materials may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved detection of arrhythmias in patients with syncope, potentially enhancing patient outcomes and treatment strategies.
How similar studies have performed: Previous studies have shown that extended cardiac monitoring can improve arrhythmia detection, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bron and 1 other locations
- Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel — Bron, France (Recruiting)
- Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin — Berlin, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Purvee Parikh
- Email: purvee.parikh@philips.com
- Phone: +1 619-929-6310
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.