Detection of Atrial Fibrillation Using PPG From Smartphone Cameras (FLASH AF)
Detection of Atrial Fibrillation Using Photoplethysmography From Smartphone Cameras
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Yosef Safi Harb, CEO
- 전화번호: +31 (0) 681885565
- 이메일: yosef@happitech.com
연구 연락처 백업
- 이름: Amanda Marinov, Regulatory
- 전화번호: +359878422979
- 이메일: a.marinov@happitech.com
연구 장소
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Overijssel
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Zwolle, Overijssel, 네덜란드, 8025 AB
- 모병
- Isala Zwolle
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연락하다:
- Fleur van Haveren, Research Cardiology
- 전화번호: 088 6248377
- 이메일: f.van.haveren@isala.nl
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수석 연구원:
- Sebastien Krul, Doctor
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Arkansas
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Jonesboro, Arkansas, 미국, 72401
- 모병
- Nair Research, LLC dba Arrhythmia Research Group LLC
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연락하다:
- Kayla Rubino
- 전화번호: 870-340-7387
- 이메일: krubino@drnairresearch.com
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수석 연구원:
- Devi Nair, Doctor
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Colorado
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Littleton, Colorado, 미국, 80210
- 모병
- South Denver Cardiology
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연락하다:
- Kathy Siegel, Clinical Research Director
- 전화번호: 720-217-6139
- 이메일: ksiegel@southdenver.com
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수석 연구원:
- Srikanth Sundaram, Doctor
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Louisiana
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New Orleans, Louisiana, 미국, 70112
- 아직 모집하지 않음
- Tulane University
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연락하다:
- Kunal Sameer, Associate Director of Ops
- 전화번호: 203-285-5666
- 이메일: ksameer@tulane.edu
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수석 연구원:
- Nassair Marrouchi, Doctor
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Oklahoma
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Oklahoma City, Oklahoma, 미국, 73134
- 모병
- CardioVascular Health Clinic
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연락하다:
- Sophie Haynes, Regulatory Director
- 전화번호: 405-696-0007
- 이메일: sophie@hightowerclinical.com
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수석 연구원:
- Monica Lo, Doctor
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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To evaluate the sensitivity and specificity of the Heart Rhythm Software
기간: 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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Sensitivity & Specificity across subgroups
기간: 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.
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through study completion, an average of 6 months
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- HAPP-CTP-FDA-2025-002
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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