Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04609683
Status:
COMPLETED
Last Update Posted:
2023-11-29
First Post:
2020-10-22
Brief Title:
Measuring Hydration Levels of Healthy and Heart Failure Patients Before During and After an Electrophysiology EP Procedure
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Introductory Non-Clinical and Clinical Trial for Measuring Hydration Levels of Healthy and Heart Failure Patients Before During and After an Electrophysiology EP Procedure
Status:
COMPLETED
Status Verified Date:
2023-11
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:
Subjects will be consented to wear the AleriTM sensor prior to during and after an Electrophysiology Procedure During this time the system will measure the following parameters from subjects HR temperature saline volumerate urine production volume USG BPO Data will be retrospectively analyzed to determine if the system effectively operates under these conditions and can effectively monitor hydration levels of subjects compared to currently available methods
Detailed Description:
Study subjects scheduled for an EP procedure who have signed an informed consent form ICF will be admitted to the study Prior to the EP procedure eg in a hospital room or operating room at NYU Medical Center either an employee of NYU or Hydrostasis will place sensor on subjects bicep forearm or wrist start the sensor and connect the sensor to mobile app to start data collection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None