NCT05809362Completed
WHOOP Abnormal Rhythm Notification
Validation of a Photoplethysmography-Based Algorithm for Detection of Atrial Fibrillation Via a Wearable Device - WHOOP Abnormal Rhythm Notification
Source: ClinicalTrials.gov · Last updated 23 Apr 2024
Brief summary (registry, in English)
The purpose of this protocol is to assess the sensitivity and specificity of a photoplethysmography (PPG)-based algorithm for the detection of atrial fibrillation as compared to a gold-standard assessment (wearable ECG patch) among a population of individuals with known atrial fibrillation and without known atrial fibrillation over a 7-day study period.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 653 (actual)
- First submitted
- 29 Mar 2023
- Start date
- 10 Apr 2023
- Primary completion date
- 25 Jan 2024
- Lead sponsor
- Yale University
- Diseases
- Atrial fibrillation
- NCT number
- NCT05809362
What you commit to
- Study type: Observational
- Participants enrolled: 653
- From 10 Apr 2023 to the primary completion date, 25 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Solid organ transplant
- Subjects taking rhythm control drugs including amiodarone, dronedarone, dofetilide, sotalol, flecainide, ibutilide, lidocaine, procainamide, propafenone, quinidine, tocainide.
Other illness
- Has implantable cardiac device (e.g., pacemaker, ICD, LVAD)
- Sensitivity or allergy to ECG patch or skin glue
- Known sensitivity to medical adhesives, isopropyl alcohol, watch bands, or electrocardiogram (ECG) electrodes including known allergy or sensitivity to polyamide, polyester, or elastane bands primarily used in wrist worn fitness devices
- Symptomatic (or active) allergic skin reactions
- Acute myocardial infarction (MI) within 90 days of screening or other cardiovascular disease that, in the opinion of the investigator, increases the risk to the subject or renders data uninterpretable.
Other
- Pre-existing WHOOP user with active account
- Unwilling to wear WHOOP 4.0 strap for one week
- Unwilling to wear BioTel (ECG patch) ePatch for one week
- WHOOP strap should be the only wearable on the arm. Individuals unwilling to adhere to the proper usage of the WHOOP strap will be excluded.
- Unwilling to install the WHOOP Mobile Application software
- Unable to provide informed consent
- Non-English speaking (as the WHOOP Mobile Application software is English only)
- Significant tremor that prevents the subject from being able to hold still.
- Pregnant women: Women who report being pregnant at the time of study participation.
Who the study is looking for
- Age \>= 22 years
- Known diagnosis of atrial fibrillation OR no history of arrhythmia as documented in the patient medical record
- Seen in a Yale New Haven Hospital-associated Primary Care or Cardiology Clinic
- Cell phone (IOS 15.0 or greater or Android 10 or greater) with an active data plan and willing to install the WHOOP Mobile Application software
- Full-time US resident
- Able to read, understand, and provide written informed consent in English
- Willing and able to participate in the study procedures as described in the consent form
- Able to communicate effectively with and follow instructions from the study staff
Age in the registry: 22 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yale University Coordinator of this site? Confirm its status | New Haven | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.