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NCT04609683 · ClinicalTrials.gov registry record · NA
Measuring Hydration Levels of Healthy and Heart Failure Patients Before, During, and After an Electrophysiology (EP) Procedure
A NA study of Cardiac Arrhythmia, sponsored by NYU Langone Health.
- Completed
- Registry status
- NA
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT04609683: Completed NA study of Cardiac Arrhythmia, sponsored by NYU Langone Health.
NCT04609683 is a NA study of Cardiac Arrhythmia that has completed, run by NYU Langone Health. The registered enrollment target is 19 participants, below the 212-participant average among 12 other Cardiac Arrhythmia trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04609683, a NA study of Cardiac Arrhythmia, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- NA
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study 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 volume/rate, 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.
Primary Outcome
Study team will compare the hydration status (changes in body water content) as predicted by the Aleri sensor to changes in volume according to the routinely reported volume exchanges. This will be a correlation study, and as such the purpose would be to use Pearsons' correlation between the device measurement and the interval changes in fluids ingested or excreted by the patient. There is no benchmark, but rather we will be looking for statistically significant correlation for any r\>.5.
Conditions Studied
Interventions
- DEVICE AleriTM sensors
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2022-09-19 |
| Est. Completion | 2023-11-05 |
| Phase | NA |
What the finished NCT04609683 record still lists
NCT04609683 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 212-participant average among 12 other Cardiac Arrhythmia trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Cardiac Arrhythmia appearing as the primary indexed condition, and to 1 intervention - of which AleriTM sensors is the first listed.
NCT04609683 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04609683 about?
NCT04609683 is a clinical study titled "Measuring Hydration Levels of Healthy and Heart Failure Patients Before, During, and After an Electrophysiology (EP) Procedure". 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 volume/rate, urine production volume, USG, BPO. Data will be retrospectively ana...
What is the current status of trial NCT04609683?
This trial is currently completed. It is a NA study. The enrollment target is 19 participants. The study started on 2022-09-19. Estimated completion is 2023-11-05.
What conditions does trial NCT04609683 study?
This clinical trial studies the following conditions: Cardiac Arrhythmia.
What interventions are being tested in trial NCT04609683?
The interventions under investigation include: AleriTM sensors (DEVICE).
Who is sponsoring clinical trial NCT04609683?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04609683 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04609683's enrollment target sits among peer trials
19 12th of 12 higher than 1 of 12 other Cardiac Arrhythmia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiac Arrhythmia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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