WHOOP ECG Software Performance Assessment Study

NCT ID: NCT06622265

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 540 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2024-07-03

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.

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)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort 1

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

Electrocardiogram recording

Intervention Type: DEVICE

ECG recording with investigational device

Cohort 2

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

Electrocardiogram recording

Intervention Type: DEVICE

ECG recording with investigational device

Interventions

Electrocardiogram recording

ECG recording with investigational device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

-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).

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Whoop Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerald Early, M.D.

Role: PRINCIPAL_INVESTIGATOR

Iqvia Pty Ltd

Locations

HOPE Research Institute

Phoenix, Arizona, United States

Valley Clinical Trials

Covina, California, United States

Valley Clinical Trials

Northridge, California, United States

Flourish Research

Winter Park, Florida, United States

IQVIA

Lenexa, Kansas, United States

Fairview Frontiers

Saint Paul, Minnesota, United States

Eximia Research-NC, LLC

Raleigh, North Carolina, United States

Countries

United States

Other Identifiers

ECG1-008

Identifier Type: -

Identifier Source: org_study_id