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NCT06351761 · ClinicalTrials.gov registry record · NA
WIBOFA - Validation of SCT02 With ECG-App for Detection of AF
A NA study of Atrial Fibrillation, sponsored by Withings.
- Completed
- Registry status
- NA
- Development phase
- 373
- Enrollment target
- 4
- Study locations
NCT06351761: Completed NA study of Atrial Fibrillation, sponsored by Withings.
NCT06351761 is a NA study of Atrial Fibrillation that has completed, run by Withings. The registered enrollment target is 373 participants, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (88% lower). The trial reports 4 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06351761, a NA study of Atrial Fibrillation, has completed, sponsored by Withings.
- COMPLETED
- Registry status
- NA
- Development phase
- 373 participants
- Enrollment target
- 4
- Study locations
Study Summary
The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app 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 IMD, compared to the reference 12-lead ECG.
Conditions Studied
Interventions
- DEVICE Investigational Device (Withings SCT02) 30 second Electrocardiogram recording
- DEVICE Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording
Study Locations (4)
Florida
- FWD Clinical Research - Boca Raton
- Diverse Clinical Research - Miami
Val de Marne
- Henri Mondor University Hospital - Créteil
Other
- Centre Cardiopole Trubert - Paris
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 373 participants |
| Start Date | 2024-06-03 |
| Est. Completion | 2025-11-26 |
| Phase | NA |
What the finished NCT06351761 record still lists
NCT06351761 is an interventional study that assigns participants to a tested intervention. The registered 373 participants enrollment target is mid-sized for trials with a published cap, below the 2,995-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (88% lower).
The record links to 1 condition, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which Investigational Device (Withings SCT02) 30 second Electrocardiogram recording is the first listed.
NCT06351761 reports a single indexed study location in Florida, Val de Marne, Other.
Frequently Asked Questions
What is clinical trial NCT06351761 about?
NCT06351761 is a clinical study titled "WIBOFA - Validation of SCT02 With ECG-App for Detection of AF". The aim of the study is to evaluate the performance of Withings SCT02 with embedded Withings ECG-app in the automatic detection of atrial fibrillation
What is the current status of trial NCT06351761?
This trial is currently completed. It is a NA study. The enrollment target is 373 participants. The study started on 2024-06-03. Estimated completion is 2025-11-26.
What conditions does trial NCT06351761 study?
This clinical trial studies the following conditions: Atrial Fibrillation.
What interventions are being tested in trial NCT06351761?
The interventions under investigation include: Investigational Device (Withings SCT02) 30 second Electrocardiogram recording (DEVICE), Reference Device (Schiller Cardiovit FT-1) 30 second Electrocardiogram recording (DEVICE).
Who is sponsoring clinical trial NCT06351761?
This trial is sponsored by Withings, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06351761 being conducted?
This trial has 4 study locations across Florida, Val de Marne. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06351761's enrollment target sits among peer trials
373 72nd of 202 higher than 131 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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