Fonction ECG WHOOP pour la détection de la fibrillation atriale dans les appareils portables
Collecte de données
Données recueillies dès le début de l'étude - ProspectiveArythmies cardiaques+3
+ Fibrillation Auriculaire
+ Maladies Cardiovasculaires
Cohorte
Suivi d'un groupe de personnes dans le temps pour mieux comprendre les causes et l'évolution d'une maladie.Résumé
Date de début de l'étude : 15 mai 2024
Date à laquelle le premier participant a commencé l'étude.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).
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.540 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Cohorte
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 22 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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).
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.Objectifs de l'étude
Objectifs principaux
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 7 sites
Valley Clinical Trials
Covina, United StatesValley Clinical Trials
Northridge, United StatesFlourish Research
Winter Park, United States