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ECG Device

Atrial Fibrillation for Atrial Fibrillation (WIBOFA Trial)

N/A
Waitlist Available
Research Sponsored by Withings
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 months
Awards & highlights

WIBOFA Trial Summary

This trial aims to test how well the Withings SCT02 device, which includes the Withings ECG app, can automatically detect atrial fibrillation.

Who is the study for?
This trial is for individuals who have or are suspected to have atrial fibrillation, a heart condition causing irregular heartbeat. Participants must be eligible based on specific criteria set by the researchers but these details were not provided.Check my eligibility
What is being tested?
The study is testing the accuracy of a new device called Withings SCT02 with an ECG-app in detecting atrial fibrillation against a standard reference device (Schiller Cardiovit FT-1) through 30-second heart rhythm recordings.See study design
What are the potential side effects?
Since this trial involves non-invasive ECG recording, side effects are minimal and may include discomfort from wearing the device or skin irritation at the site of electrode placement.

WIBOFA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Co- 1 - Sensitivity of Investigational Device
Co- 2 - Specificity of Investigational Device
Secondary outcome measures
Quality of plots measured by the IMD - ECG Waveform Visibility
Quality of plots measured by the IMD - ECG Waveforms Intervals
Quality of plots measured by the IMD - ECG Waveforms Polarity
+2 more

WIBOFA Trial Design

2Treatment groups
Experimental Treatment
Group I: Normal Sinus RhythmExperimental Treatment2 Interventions
Simultaneous ECG recording of patient with Normal Sinus Rhythm with investigational and reference devices
Group II: Atrial FibrillationExperimental Treatment2 Interventions
Simultaneous ECG recording of patient with Atrial Fibrillation with investigational and reference devices

Find a Location

Who is running the clinical trial?

WithingsLead Sponsor
20 Previous Clinical Trials
4,633 Total Patients Enrolled
8 Trials studying Atrial Fibrillation
2,644 Patients Enrolled for Atrial Fibrillation

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants currently able to apply for enrollment in this research study?

"As per clinicaltrials.gov, this specific trial is not currently accepting new participants. It was initially listed on April 1st, 2024, with the most recent update made on April 4th of the same year. Despite its closure to enrollment, there are a considerable 481 alternative trials presently open for participant recruitment."

Answered by AI

What are the primary objectives of this scientific study?

"Furthermore, Rhythm classification based on various heart rate ranges will be explored. Specifically focusing on Sinus"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
WIBOFA - Validation of SCT02 With ECG-App for Detection of AF
2024. "WIBOFA - Validation of SCT02 With ECG-App for Detection of AF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06351761.
~180 spots leftby Jan 2025
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