WHOOP ECG Software Performance Assessment Study

NCT06622265 | Completed FDA Device

• 1 other identifier: ECG1-008
• Study Type: observational
• Target: 540
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Atrial Fibrillation (AF)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  1 Day

Study Arms (2)

Cohort 1

Subjects whose ECG is interpreted as normal sinus rhythm during the screening assessment

Device: Electrocardiogram recording

Cohort 2

Subjects whose ECG is interpreted as atrial fibrillation during the screening assessment

Device: Electrocardiogram recording

Interventions

Electrocardiogram recording DEVICE

ECG recording with investigational device

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Whoop Inc.: lead

Study Sites (7)

HOPE Research Institute

Phoenix, Arizona, 85018, United States

Location

Valley Clinical Trials

Covina, California, 91723, United States

Location

Valley Clinical Trials

Northridge, California, 91325, United States

Location

Flourish Research

Winter Park, Florida, 32789, United States

Location

IQVIA

Lenexa, Kansas, 66219, United States

Location

Fairview Frontiers

Saint Paul, Minnesota, 55102, United States

Location

Eximia Research-NC, LLC

Raleigh, North Carolina, 27607, United States

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gerald Early, M.D.

  Iqvia Pty Ltd

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 2, 2024
• Study Start: May 15, 2024
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Locations

US (7)