Detection of Atrial Fibrillation Using PPG From Smartphone Cameras (FLASH AF)
Detection of Atrial Fibrillation Using Photoplethysmography From Smartphone Cameras
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Yosef Safi Harb, CEO
- 電話番号：+31 (0) 681885565
- メール：yosef@happitech.com
研究連絡先のバックアップ
- 名前：Amanda Marinov, Regulatory
- 電話番号：+359878422979
- メール：a.marinov@happitech.com
研究場所
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Arkansas
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Jonesboro、Arkansas、アメリカ、72401
- 募集
- Nair Research, LLC dba Arrhythmia Research Group LLC
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コンタクト：
- Kayla Rubino
- 電話番号：870-340-7387
- メール：krubino@drnairresearch.com
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主任研究者：
- Devi Nair, Doctor
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Colorado
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Littleton、Colorado、アメリカ、80210
- 募集
- South Denver Cardiology
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コンタクト：
- Kathy Siegel, Clinical Research Director
- 電話番号：720-217-6139
- メール：ksiegel@southdenver.com
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主任研究者：
- Srikanth Sundaram, Doctor
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Louisiana
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New Orleans、Louisiana、アメリカ、70112
- まだ募集していません
- Tulane University
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コンタクト：
- Kunal Sameer, Associate Director of Ops
- 電話番号：203-285-5666
- メール：ksameer@tulane.edu
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主任研究者：
- Nassair Marrouchi, Doctor
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Oklahoma
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Oklahoma City、Oklahoma、アメリカ、73134
- 募集
- CardioVascular Health Clinic
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コンタクト：
- Sophie Haynes, Regulatory Director
- 電話番号：405-696-0007
- メール：sophie@hightowerclinical.com
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主任研究者：
- Monica Lo, Doctor
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Overijssel
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Zwolle、Overijssel、オランダ、8025 AB
- 募集
- Isala Zwolle
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コンタクト：
- Fleur van Haveren, Research Cardiology
- 電話番号：088 6248377
- メール：f.van.haveren@isala.nl
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主任研究者：
- Sebastien Krul, Doctor
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参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To evaluate the sensitivity and specificity of the Heart Rhythm Software
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Sensitivity & Specificity across subgroups
時間枠：through study completion, an average of 6 months
|
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
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- HAPP-CTP-FDA-2025-002
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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