Detection of Atrial Fibrillation Using PPG From Smartphone Cameras (FLASH AF)
Detection of Atrial Fibrillation Using Photoplethysmography From Smartphone Cameras
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Atrial fibrillation (AF) is the most common sustained arrhythmia worldwide, and its prevalence is increasing and is expected to continue increasing for decades,. Detection of AF episodes may be useful for the identification of undiagnosed AF and in making clinical management decisions that include oral anticoagulation, restoration and maintenance of sinus rhythm, control of ventricular rate, and risk factor modification. Treatment of AF is associated with improvements of quality of life, stroke prevention, and reduced risk of heart failure.
Traditionally, diagnosis of AF is done using an electrocardiogram, with low amplitude or absent p-waves and narrow complex "irregularly irregular" pattern intervals seen on the ECG,. After diagnosis, there are a variety of methods that can be used to manage AF. Ambulatory ECG monitoring, implantable monitoring devices, and over-the-counter wrist-worn devices have been used to manage patients with AF,,. However, these devices are inconvenient and expensive which limits their wide adoption into clinical practice. There is an unmet clinical need for an easy to use and inexpensive over-the-counter FDA-cleared products that can detect episodes of AF in real-time and notify patients to seek out further care when AF is suspected.
Recent technological advancements have allowed for the identification of AF using smartwatches, with device manufacturers gaining over-the-counter regulatory clearance for their irregular heart rate detection algorithms,. These wrist-worn devices use a light-based measurement method called photoplethysmography (PPG) to measure changes in light absorbance and reflectance to understand changes in blood flow in superficial vasculature. The waveform generated from this measurement can be used to measure parameters like pulse rate, respiratory rate, pulse rate variability and others in addition to detecting AF. The increasing ubiquity of smartphones worldwide has led to greater availability of heart rhythm diagnostics using smartphone photoplethysmography (PPG). Smartphone camera PPG technology uses the light-emitting diode in cameras to measure pulsatile changes in light intensity that are reflected from a finger and can be used to detect AF. The widespread availability of this technology has the potential to improve the accessibility and convenience of heart rhythm monitoring, particularly in remote or underserved areas. This could result in improvements in early detection and management of AF, leading to better patient outcomes. Several smartphone PPG-based algorithms have been developed that utilize smartphones' built-in cameras to detect AF. The sensitivity and specificity of these algorithms for the detection of AF range between 81%-100% and 85%-100% respectively. However, there is a lack of evidence regarding the performance of these algorithms in detecting AF in an out-of-hospital setting using a gold-standard reference.
Happitech has developed a proprietary software development kit (SDK) that can be utilized to measure patients' cardiovascular parameters and identify potential pathologies including AF. Happitech's algorithm requires users to place a digit directly against their phone camera, and the camera and underlying algorithm detect subtle differences in blood flow to calculate physiological parameters for monitoring and clinical use.
The purpose of this study is to validate the performance of Happitech's PPG-based algorithm for the detection of AF against a 12-lead ECG in a diverse population of patients including cardiology patients being evaluated as inpatients or at a cardiology clinic visit.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Yosef Safi Harb, CEO
- Номер телефона: +31 (0) 681885565
- Электронная почта: yosef@happitech.com
Учебное резервное копирование контактов
- Имя: Amanda Marinov, Regulatory
- Номер телефона: +359878422979
- Электронная почта: a.marinov@happitech.com
Места учебы
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Overijssel
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Zwolle, Overijssel, Нидерланды, 8025 AB
- Рекрутинг
- Isala Zwolle
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Контакт:
- Fleur van Haveren, Research Cardiology
- Номер телефона: 088 6248377
- Электронная почта: f.van.haveren@isala.nl
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Главный следователь:
- Sebastien Krul, Doctor
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Arkansas
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Jonesboro, Arkansas, Соединенные Штаты, 72401
- Рекрутинг
- Nair Research, LLC dba Arrhythmia Research Group LLC
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Контакт:
- Kayla Rubino
- Номер телефона: 870-340-7387
- Электронная почта: krubino@drnairresearch.com
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Главный следователь:
- Devi Nair, Doctor
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Colorado
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Littleton, Colorado, Соединенные Штаты, 80210
- Рекрутинг
- South Denver Cardiology
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Контакт:
- Kathy Siegel, Clinical Research Director
- Номер телефона: 720-217-6139
- Электронная почта: ksiegel@southdenver.com
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Главный следователь:
- Srikanth Sundaram, Doctor
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Louisiana
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New Orleans, Louisiana, Соединенные Штаты, 70112
- Еще не набирают
- Tulane University
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Контакт:
- Kunal Sameer, Associate Director of Ops
- Номер телефона: 203-285-5666
- Электронная почта: ksameer@tulane.edu
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Главный следователь:
- Nassair Marrouchi, Doctor
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Oklahoma
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Oklahoma City, Oklahoma, Соединенные Штаты, 73134
- Рекрутинг
- CardioVascular Health Clinic
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Контакт:
- Sophie Haynes, Regulatory Director
- Номер телефона: 405-696-0007
- Электронная почта: sophie@hightowerclinical.com
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Главный следователь:
- Monica Lo, Doctor
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- Adults aged 22 years or older
- Owns a smartphone and knows how to operate and navigate different applications.
- Individuals able to read, understand, and sign the consent form.
- Cardiology patients consulting the cardiac outpatient clinic.
- History of persistent AF or other cardiac rhythm
Exclusion Criteria:
- Participants with cognitive impairments
- Individuals who cannot read, speak, and/or understand English
- Patients with implantable neurostimulators, cardiac implantable device in an atrial or ventricular paced rhythm documented on a 12-lead ECG during the initial study visit
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
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Sinus Rhythm
Patient visiting the Cardiology Clinic in Sinus Rhythm
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12 Lead ECG is compared to a smartphone based PPG
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Atrial Fibrillation
Patient visiting the Cardiology Clinic in Atrial Fibrillation
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12 Lead ECG is compared to a smartphone based PPG
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Other
Patient visiting the Cardiology Clinic with neither Sinus Rhythm or Atrial Fibrillation
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12 Lead ECG is compared to a smartphone based PPG
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
To evaluate the sensitivity and specificity of the Heart Rhythm Software
Временное ограничение: Through study completion, an average of 6 months
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To evaluate the sensitivity and specificity of the Heart Rhythm Software algorithm running on a commercially available smartphone to detect atrial fibrillation segments using photoplethysmography (PPG) as measured through the phone's camera. Se is defined as the percentage of patients with 90 second interval recordings scored by the Heart Rhythm Software algorithm as AF, out of all intervals determined by the Clinical Adjudication Committee (CAC) to be AF (gold standard). Sp is defined as the percentage of patients with 90 second intervals scored by the Heart Rhythm Software algorithm as NSR out of all ECG recordings determined by the CAC to be NSR. |
Through study completion, an average of 6 months
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Sensitivity & Specificity across subgroups
Временное ограничение: through study completion, an average of 6 months
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The accuracy of the Happitech Heart Rhythm Software algorithm in detecting irregular rhythm suspected of AF and regular rhythm suspected normal sinus rhythm will be further investigated in subgroups defined by ethnicity, race, BMI, age group, smartphone type, and Fitzpatrick scale score.
The sensitivity and specificity will be presented as an estimate and associated 95% CI's, as well as a Chi-square or Fisher's Exact p-value to assess if all levels of the subgroup are homogeneous.
|
through study completion, an average of 6 months
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- HAPP-CTP-FDA-2025-002
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .