TerminatedNot Applicable

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

Stopped: 1\. Slow Enrollment. 2. Issues regarding reimbursement of product

France, Germany55 participantsStarted 2023-11-09

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)

Exclusion criteria

✕. 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

What they're measuring

Diagnostic yield (frequency) of clinically actionable arrythmia

Timeframe: Up to 7 days

Trial details

NCT IDNCT06310707

SponsorPhilips Clinical & Medical Affairs Global

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-10

View on ClinicalTrials.gov More Arrythmia trials