Clinical trial NCT06310707: Arrhythmia Identification in Syncope Patients: ePatch® Versus 24h Holter
Official title: A Randomized Controlled Study to Identify Clinically Actionable Arrhythmia Using the ePatch® Extended Wear Holter vs. Standard Wear Holter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Arrythmia
Syncope
Keywords: Clinically Actionable Arrhythmia
Symptoms of syncope
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2024-03-15
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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.

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.

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

Primary outcomes:
measure: Diagnostic yield (frequency) of clinically actionable arrythmia
timeFrame: Up to 7 days
Secondary outcomes:
measure: Number of Atrial Fibrillation (AF) diagnoses > 30 seconds
timeFrame: Up to 7 days
measure: Occurrence of symptomatic events
timeFrame: Up to 7 days
measure: Number of Clinically actionable arrhythmia
timeFrame: Up to 7 days
measure: Patient Quality of Life as measured by EQ-5D-5L
timeFrame: Up to 7 days
measure: Patient Quality of Life as measured by Patient Experience Survey
timeFrame: Up to 7 days
measure: Cost related to cardiac monitoring
timeFrame: Up to 7 days
measure: Time Holter is worn/ removed
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin
Study officials:
References: