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

Launched by PHILIPS CLINICAL & MEDICAL AFFAIRS GLOBAL · Mar 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well a new device called the ePatch Holter can detect heart rhythm problems in patients who have experienced fainting spells (called syncope). The goal is to see if wearing the ePatch for a full week can find more significant heart issues compared to the standard method, which involves a 24-hour heart monitor. The trial is currently looking for participants aged 18 and older who are experiencing symptoms that require heart monitoring and can wear the device for up to seven days.

To be eligible, participants should not have a chronic heart condition like atrial fibrillation, nor should they have a pacemaker or defibrillator. They should be able to apply the device on their own and be willing to attend follow-up visits. If you join this study, you can expect to wear the ePatch at home, where it will monitor your heart continuously for a week. The information gathered will help doctors understand your heart's health better and guide any necessary treatment.

Gender

ALL

Eligibility 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