Ignite Creation Date:
2025-12-24 @ 1:10 PM
Ignite Modification Date:
2025-12-27 @ 9:31 PM
Study NCT ID:
NCT02133261
Status:
COMPLETED
Last Update Posted:
2014-06-26
First Post:
2014-05-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study
Sponsor:
Bardy Diagnostics, Inc.
Organization:
Study Overview
Official Title:
BDx 7 Day ECG Patch: Electrode Adhesion Clinical Study
Status:
COMPLETED
Status Verified Date:
2014-06
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:
The purpose of this research study is to learn if a new 7 day patch ECG recording monitor can serve the same purpose as standard monitoring systems. The new 7day patch is significantly smaller and lighter than previous ECG recorders.
Detailed Description:
The primary purpose of this research is to evaluate ECG signal quality of the BDx 7 day ECG Patch heart monitor after 7 full days of wear, establishing that the device is safe and effective to wear for up to 7 days.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: