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

Philips

Status: Enrolling

Conditions: Syncope; Arrythmia

Treatments: Device: ePatch ® Extended Wear Holter (EWH)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06310707

EU RCT: ePatch vs 24h Holter

2022-A02338-35 (Other Identifier)

EA4/071/23 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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128 participants in 2 patient groups

ePatch® Extended Wear Holter (EWH) Arm

Experimental group

Description:

Participants will undergo long-term continuous ambulatory ECG recording of 7-day duration

Treatment:

Device: ePatch ® Extended Wear Holter (EWH)

Standard of Care

No Intervention group

Description:

Participants will undergo 24 hours of continuous ECG recording.