Atrial Fibrillation (AF)NCT06622265
WHOOP ECG Software Performance Assessment Study
An observational study of Atrial Fibrillation (AF), run by Whoop Inc. at 7 sites in United States.
Trial summary
The purpose of the study is to evaluate the performance of ECG classification algorithms and their ability to classify heart rhythms into multiple categories of rhythms and heart rates. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Electrocardiogram recording
- Type of treatment
- Medical device
- How many people
- 540 participants
- Where
- 7 sitesUnited States
- Study dates
- 15 May 2024to 3 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will include adults seen in primary care and cardiology clinics associated with a single health system or subjects recruited through study advertisement. The prospective cohort will comprise two distinct populations - individuals with a known history of persistent atrial fibrillation and individuals without a history of cardiac arrhythmia of any kind.
Who may be able to join
- Aged 22 years or older.
- Ability to provide informed consent.
- Willing to participate and to follow the procedures per the Principal Investigator's instructions.
- Resided in the United States.
- Wrist circumference: 130 mm to 245 mm at band wear position.
- Previous medical history of persistent, paroxysmal, or permanent or chronic AF and being in AF at time of enrollment (AF cohort only).
- No known history of AF and being in normal sinus rhythm at the time of enrollment (NSR cohort only).
Who cannot join
- -Subjects with an implantable pacemaker device or implantable cardioverter- defibrillator device.
- Medical history of a life-threatening cardiac arrhythmia, e.g., ventricular tachycardia or fibrillation.
- Any known allergies to medical adhesives, isopropyl alcohol, or ECG patch.
- Any known allergy or sensitivity to thermoplastics, metals with physical vapor deposition (PVD) coatings or Elastane used in the wrist fitness devices.
- Clinically significant body tremors that compromise study measurements.
- Pregnant at the time of enrollment.
Show all 15Show fewer
- Any physical disability that prevents safe and adequate testing.
- Physical or medical impairments that preclude exercise testing, including, but not limited to, back pain and leg claudication.
- Mental impairment as determined by the Investigator, or designee.
- Subjects with any medical history, physical examination finding, vital sign or other finding or assessment that could compromise subject safety, study integrity or accurate assessment of study objectives. This includes, but is not limited to, known untreated medical conditions that may be considered clinically significant, such as significant anemia, electrolyte imbalance, untreated or uncontrolled thyroid disease, and open wound(s) in the area of test band positioning.
- Vital sign measurements, medical history or physical examination finding that makes the subject inappropriate for participation according to the Investigator.
- Scarring, tattoos, large, pigmented moles, or other skin pathology in the area of sensor location.
- Severe skin conditions on either wrist, that would preclude wearing the sensor. Severe symptomatic skin injury, disorder, allergy, or disease such as eczema, rosacea, impetigo, dermatomyositis or contact dermatitis on wrist or other areas where sensors or electrodes would be placed.
- Clinically significant hand tremors as judged by the Investigator.
- Participated in phase 1 of the study (Only for phase 2 cohort).
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Valley Clinical Trials
Covina, California, 91723
IQVIA
Lenexa, Kansas, 66219
Valley Clinical Trials
Northridge, California, 91325
HOPE Research Institute
Phoenix, Arizona, 85018
Eximia Research-NC, LLC
Raleigh, North Carolina, 27607
Fairview Frontiers
Saint Paul, Minnesota, 55102
Flourish Research
Winter Park, Florida, 32789
About this study
Official title: Multi-phase, Prospective, Multicenter, Non-interventional, Pre-market, Non-randomized, Open-label Study to Evaluate the Clinical Performance of the WHOOP ECG Feature
The purpose of the study is to evaluate the performance of ECG classification algorithms and their ability to classify heart rhythms into multiple categories of rhythms and heart rates.
Read the detailed description
Atrial fibrillation (Afib) is the most common cardiac arrhythmia in the United States, affecting up to one in four individuals across the lifespan, and is associated with substantial morbidity and mortality. Fifteen percent of strokes in the United States are attributable to Afib, and nearly 20% of these occur in individuals with no prior Afib history. Because Afib is often paroxysmal, one-time screening is unlikely to capture those at risk. Thus, there has been an increasing interest in leveraging monitoring for Afib via wearable devices, which provide a novel method to monitor Afib and determine the burden of Afib in the general population.
The primary objective of this study is to assess the sensitivity and specificity of the investigation device (WHOOP ECG Feature) for the detection of Afib as compared to a gold-standard reference (12-Lead ECG Holter Device).
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Electrocardiogram recording
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrocardiogram recordingDevice
ECG recording with investigational device
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Subjects whose ECG is interpreted as normal sinus rhythm during the screening assessment Receives: Device: Electrocardiogram recording | |
| Cohort 2 | Subjects whose ECG is interpreted as atrial fibrillation during the screening assessment Receives: Device: Electrocardiogram recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity of the WHOOP ECG Feature for detection of sinus rhythm
Specificity is defined as the True Negatives/(True Negatives + False Positives). A true normal sinus rhythm reading will have a 12-lead ECG reading consistent with normal sinus rhythm. A true negative is defined as individuals who have normal sinus rhythm reported on their ECGs from both the WHOOP ECG Feature and the 12-lead ECG Holter Device. A false positive is defined as individuals who receive an ECG with atrial fibrillation by the WHOOP ECG Feature but their 12-lead ECG has an atrial fibrillation determined by adjudication.
Measured: 1 Day
Sensitivity of the WHOOP ECG Feature for detection of atrial fibrillation
Sensitivity is defined as the True Positives/(True Positives + False Negatives). A true atrial fibrillation reading will have an 12-lead ECG reading consistent with atrial fibrillation. A true positive is defined as individuals who have atrial fibrillation reported on their WHOOP ECGs and on the 12-lead ECG from the Holter Device. A false negative is defined as individuals who receive an ECG with atrial fibrillation with the 12-lead ECG as determined by adjudication but their WHOOP ECG Feature determination is Normal Sinus Rhythm.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start15 May 2024
- Primary completion3 Jul 2024
- Study completion3 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 540 participants (actual)
Sponsor and investigators
- Lead sponsor
- Whoop Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerald Early, M.D., Principal investigator, IQVIA Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06622265
- Sponsor's protocol ID
- ECG1-008
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-phase, Prospective, Multicenter, Non-interventional, Pre-market, Non-randomized, Open-label Study to Evaluate the Clinical Performance of the WHOOP ECG Feature
- ClinicalTrials.gov ID
- NCT06622265
- Acronym / sponsor ID
- ECG1-008
- Conditions
- Atrial Fibrillation (AF)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 540 participants (actual)
- Lead sponsor
- Whoop Inc.Industry (pharma, biotech, devices)
- Study start
- 15 May 2024 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 3 Jul 2024 (actual)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the performance of ECG classification algorithms and their ability to classify heart rhythms into multiple categories of rhythms and heart rates.
Detailed description
Atrial fibrillation (Afib) is the most common cardiac arrhythmia in the United States, affecting up to one in four individuals across the lifespan, and is associated with substantial morbidity and mortality. Fifteen percent of strokes in the United States are attributable to Afib, and nearly 20% of these occur in individuals with no prior Afib history. Because Afib is often paroxysmal, one-time screening is unlikely to capture those at risk. Thus, there has been an increasing interest in leveraging monitoring for Afib via wearable devices, which provide a novel method to monitor Afib and determine the burden of Afib in the general population.
The primary objective of this study is to assess the sensitivity and specificity of the investigation device (WHOOP ECG Feature) for the detection of Afib as compared to a gold-standard reference (12-Lead ECG Holter Device).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | Device: Electrocardiogram recordingSubjects whose ECG is interpreted as normal sinus rhythm during the screening assessment |
| Cohort 2 | – | Device: Electrocardiogram recordingSubjects whose ECG is interpreted as atrial fibrillation during the screening assessment |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include adults seen in primary care and cardiology clinics associated with a single health system or subjects recruited through study advertisement. The prospective cohort will comprise two distinct populations - individuals with a known history of persistent atrial fibrillation and individuals without a history of cardiac arrhythmia of any kind.
Key inclusion criteria (7 listed)
- Aged 22 years or older.
- Ability to provide informed consent.
- Willing to participate and to follow the procedures per the Principal Investigator's instructions.
- Resided in the United States.
- Wrist circumference: 130 mm to 245 mm at band wear position.
Key exclusion criteria (15 listed)
- -Subjects with an implantable pacemaker device or implantable cardioverter- defibrillator device.
- Medical history of a life-threatening cardiac arrhythmia, e.g., ventricular tachycardia or fibrillation.
- Any known allergies to medical adhesives, isopropyl alcohol, or ECG patch.
- Any known allergy or sensitivity to thermoplastics, metals with physical vapor deposition (PVD) coatings or Elastane used in the wrist fitness devices.
- Clinically significant body tremors that compromise study measurements.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electrocardiogram recordingECG recording with investigational device | Device | Cohort 1, Cohort 2 |
Primary outcome
Specificity of the WHOOP ECG Feature for detection of sinus rhythm
Time frame: 1 Day
Specificity is defined as the True Negatives/(True Negatives + False Positives). A true normal sinus rhythm reading will have a 12-lead ECG reading consistent with normal sinus rhythm. A true negative is defined as individuals who have normal sinus rhythm reported on their ECGs from both the WHOOP ECG Feature and the 12-lead ECG Holter Device. A false positive is defined as individuals who receive an ECG with atrial fibrillation by the WHOOP ECG Feature but their 12-lead ECG has an atrial fibrillation determined by adjudication.
Sensitivity of the WHOOP ECG Feature for detection of atrial fibrillation
Time frame: 1 Day
Sensitivity is defined as the True Positives/(True Positives + False Negatives). A true atrial fibrillation reading will have an 12-lead ECG reading consistent with atrial fibrillation. A true positive is defined as individuals who have atrial fibrillation reported on their WHOOP ECGs and on the 12-lead ECG from the Holter Device. A false negative is defined as individuals who receive an ECG with atrial fibrillation with the 12-lead ECG as determined by adjudication but their WHOOP ECG Feature determination is Normal Sinus Rhythm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerald Early, M.D. principal investigator
IQVIA Pty Ltd
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by Whoop Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity of the WHOOP ECG Feature for detection of sinus rhythm (time frame: 1 Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.