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NCT05316337 · ClinicalTrials.gov registry record · NA
Withings ECG-Monitor Study
A NA study of Atrial Fibrillation, sponsored by Withings.
- Completed
- Registry status
- NA
- Development phase
- 650
- Enrollment target
- 10
- Study locations
NCT05316337: Completed NA study of Atrial Fibrillation, sponsored by Withings.
NCT05316337 is a NA study of Atrial Fibrillation that has completed, run by Withings. The registered enrollment target is 650 participants, below the 2,994-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (78% lower). The trial reports 10 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05316337, a NA study of Atrial Fibrillation, has completed, sponsored by Withings.
- COMPLETED
- Registry status
- NA
- Development phase
- 650 participants
- Enrollment target
- 10
- Study locations
Study Summary
The aim of the study is to evaluate the performance of Withings WBS08 with embedded Withings ECG Monitor in the automatic detection of atrial fibrillation
Primary Outcome
Sensitivity (percentage of true positives) in detecting AF from conclusive recordings generated by the software under test, that is recordings resulting in a classification of AF or SR by the SUT, compared to the reference 12-lead ECG.
Conditions Studied
Interventions
- DEVICE Electrocardiogram recording
Study Locations (10)
Florida
- FWD Clinical Research - Boca Raton
- Florida Cardiovascular Research - Hialeah
- Diverse Clinical Research - Miami
- The Angel Medical Research - Miami Lakes
Texas
- Texas Heart Institute - Houston
- LINQ Research LLC - Pearland
Illinois
- American Institute of Therapeutics - Lake Bluff
Louisiana
- Cambridge Medical Trials - Alexandria
New York
- Heartbeat Health - New York
Île-de-France Region
- Henri-Mondor Hospital - Créteil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 650 participants |
| Start Date | 2022-07-15 |
| Est. Completion | 2023-09-01 |
| Phase | NA |
What the finished NCT05316337 record still lists
NCT05316337 is an interventional study that assigns participants to a tested intervention. The registered 650 participants enrollment target is mid-sized for trials with a published cap, below the 2,994-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 1 intervention - of which Electrocardiogram recording is the first listed.
NCT05316337 lists 10 locations in 6 states (Florida, Texas, Illinois).
Frequently Asked Questions
What is clinical trial NCT05316337 about?
NCT05316337 is a clinical study titled "Withings ECG-Monitor Study". The aim of the study is to evaluate the performance of Withings WBS08 with embedded Withings ECG Monitor in the automatic detection of atrial fibrillation
What is the current status of trial NCT05316337?
This trial is currently completed. It is a NA study. The enrollment target is 650 participants. The study started on 2022-07-15. Estimated completion is 2023-09-01.
What conditions does trial NCT05316337 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT05316337?
The interventions under investigation include: Electrocardiogram recording (DEVICE).
Who is sponsoring clinical trial NCT05316337?
This trial is sponsored by Withings, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05316337 being conducted?
This trial has 10 study locations across Florida, Illinois, Louisiana, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05316337's enrollment target sits among peer trials
650 46th of 202 higher than 156 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation 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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