Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310707
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-11-29
Brief Title:
Arrhythmia Identification in Syncope Patients ePatch Versus 24h Holter
Sponsor:
Philips Clinical Medical Affairs Global
Organization:
Philips Clinical Medical Affairs Global
Study Overview
Official Title:
A Randomized Controlled Study to Identify Clinically Actionable Arrhythmia Using the ePatch Extended Wear Holter vs Standard Wear Holter
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 to wear either the Philips ePatch Extended Wear Holter 7 day or Standard Wear Holter 24 hours Randomization will be balanced for gender
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-A02338-35 | OTHER | None | None |
| EA407123 | OTHER | German Ethics Committee_Charité Universitätsmedizin Berlin | None |