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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A02338-35 | Other Identifier | ANSM, French competent authority | |
| EA4/071/23 | Other Identifier | German Ethics Committee_Charité Universitätsmedizin Berlin |
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1. Slow Enrollment. 2. Issues regarding reimbursement of product
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ePatch® Extended Wear Holter (EWH) Arm | Experimental | Participants will undergo long-term continuous ambulatory ECG recording of 7-day duration |
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| Standard of Care | No Intervention | Participants will undergo 24 hours of continuous ECG recording. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ePatch ® Extended Wear Holter (EWH) | Device | Diagnostic Test: Extended ECG investigation • An ambulatory ECG recordings with a duration of 7 days using Philips ePatch (https://www.myheartmonitor.com/device/epatch/) will be applied |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic yield (frequency) of clinically actionable arrythmia | In patients indicated for cardiac monitoring due to syncope, show that the diagnostic yield (frequency) of clinically actionable arrythmia with 7 days of monitoring using the ePatch Extended Wear Holter is superior to what would be seen with the Standard Wear Holter (24 hours). | Up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Atrial Fibrillation (AF) diagnoses > 30 seconds | Number of Atrial Fibrillation (AF) diagnoses > 30 seconds with 7 days of monitoring using the ePatch Extended Wear Holter vs. Standard Wear Holter (24 hours). | Up to 7 days |
| Occurrence of symptomatic events |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospices Civils de Lyon - Hôpital Cardiologique Louis Pradel | Bron | 69677 Cedex | France | |||
| Deutsches Herzzentrum der Charité (DHZC) - Campus Benjamin Franklin |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D013575 | Syncope |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
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Occurrence of symptomatic events in 7 days of monitoring using the ePatch Extended Wear Holter vs. Standard Wear Holter (24 hours). |
| Up to 7 days |
| Number of Clinically actionable arrhythmia | Clinically actionable arrhythmia yield vs days of data collected
| Up to 7 days |
| Patient Quality of Life as measured by EQ-5D-5L | Patient Quality of Life will be measured using the EQ-5D-5L at 24-hours (Standard Wear Holter and ePatch) and at end of service (ePatch arm only, at 7 days). The EQ-5D-5L stands for EuroQol, 5 dimensions, 5 levels. EQ-5D-5L comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). Higher scores mean a worse outcome. | Up to 7 days |
| Patient Quality of Life as measured by Patient Experience Survey | Patient Quality of Life will be measured using survey data at 24-hours (Standard Wear Holter and ePatch) and at end of service (7 days for ePatch arm) Each question in the Patient Experience Survey has 5 levels: no problems (1), slight problems (2), moderate problems (3), severe problems (4) and extreme problems (5). Higher scores mean a worse outcome. | Up to 7 days |
| Cost related to cardiac monitoring | - Compare clinical workflow costs from 7 days of cardiac monitoring using the ePatch Extended Wear Holter vs. 24 hours of cardiac monitoring with Standard Wear Holter. | Up to 7 days |
| Time Holter is worn/ removed | Compare time Holter is worn/removed - Assess via diary | Up to 7 days |
| Berlin |
| D-12203 |
| Germany |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |