Atrial Fibrillation (AF)NCT07154303
Testing the Performance of Smartphones and Their Accessories in Detecting Irregularly Irregular Heart Rhythm
An observational study of Atrial Fibrillation (AF), run by The University of Hong Kong at 1 site in China.
Trial summary
The purpose of this 4-in-1 observational study is to test the performance of artificial intelligences (AIs) in distinguishing irregularly irregular heart rhythm called atrial fibrillation (AF) from normal heart rhythm using physiological signals collected by smartphones' built-in hardware and/or external accessories. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- Computer algorithms
- How many people
- 209 participants
- Where
- 1 siteChina
- Study dates
- 27 Aug 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- Adult, Older adult
Study population: Hospital cardiology patients
Who may be able to join
- Age: ≥22 years (adult)
- Patients who have one of the following:
- Permanent atrial fibrillation, or
- Long-standing persistent atrial fibrillation (12 months or longer), or
- Confirmed 12-lead ECG diagnosis for persistent atrial fibrillation (> 7 days) or sinus rhythm within 12 months at the time of their normal attendance at the hospital
Who cannot join
- Any of the following:
- Implanted active medical devices in the torso, such as pacemakers and defibrillators
- Patients without atrial fibrillation who have another arrhythmia
- Completely missing one or more limbs, or missing any hand
- Disability in using their hands or arms
- Lack of both index fingers, or all fingers in any hand
Show all 9Show fewer
- Both index fingers with any of the following characteristics:
- Tattooed/inked
- Reduced blood flow in the fingertip (e.g. perniosis or callus formation)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Smartphone-Based Use of Phonocardiography, Electrocardiography Accessory, and/or Facial Photoplethysmography to Detect Atrial Fibrillation: Diagnostic Performance Study
The purpose of this 4-in-1 observational study is to test the performance of artificial intelligences (AIs) in distinguishing irregularly irregular heart rhythm called atrial fibrillation (AF) from normal heart rhythm using physiological signals collected by smartphones' built-in hardware and/or external accessories.
Participants will:
Read more
- Have their weight, height, resting heart rate and blood pressures measured
- Have 12-lead electrocardiogram (ECG) of their heart electrical activities recorded
- Have their heart sounds and 1-lead ECG recorded from their chest, and optical-based blood flow data (photoplethysmography or PPG) and 1-lead ECG recorded from their fingers using smartphones' built-in microphone, camera, and/or external accessories
- Optionally have their optical-based blood flow data recorded from their face using smartphones' built-in camera (remote PPG or rPPG).
The researchers will also create a database containing the physiological signals collected in this study along with the participants' medically relevant information to help train and test future AIs for medical applications.
Read the detailed description
4 observational studies have been combined into 1 observational study to share the same pool of participants. These 4 studies are designated as AUSC-AF, ECG-AF, AUSC+ECG-AF, and rPPG-AF corresponding to the signal modality/modalities used for AF detection (see outcome measures) and designated as AUSC/ECG/rPPG-AF when combined as 1 study.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- Computer algorithms
- Keywords
- Smartphone, Persistent Atrial Fibrillation, Mobile Health, mHealth, Telemedicine, Artificial Intelligence, Heart Sounds, Phonocardiography, Photoplethysmography, Electrocardiography, 12-Lead ECG, 12-Lead EKG, 12-Lead Electrocardiography, ECG, EKG, Electrocardiogram, Electrocardiograph
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer algorithmsDiagnostic test
Also called ausculto®, Vitogram®, FacialAI
Computer algorithms that are designed to perform heart sound, electrocardiography (ECG), and/or facial photoplethysmography (rPPG) analysis on data collected from smartphone's internal hardware and/or external accessories.
| Study group | Role | What they receive |
|---|---|---|
| Atrial Fibrillation | Not described Receives: Diagnostic Test: Computer algorithms | |
| Sinus Rhythm | Not described Receives: Diagnostic Test: Computer algorithms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differentiation of Atrial Fibrillation from Sinus Rhythm in Heart Sound Recordings
AUSC-AF: Identification of atrial fibrillation (AF) from sinus rhythm in recorded heart sounds (phonocardiogram [PCG]) as verified by the gold standard 12-lead electrocardiography (ECG) interpretation, measured in the form of sensitivity and specificity.
Measured: Day 0
Secondary outcomes (4)
Differentiation of Atrial Fibrillation from Sinus Rhythm in Heart Sound Recordings
AUSC-AF: Identification of atrial fibrillation from sinus rhythm in recorded heart sounds (phonocardiogram [PCG]) as verified by the gold standard 12-lead ECG interpretation, measured in the form of positive and negative predictive values, and accuracy.
Measured: Day 0
Differentiation of Atrial Fibrillation from Sinus Rhythm in 1-Lead ECG Signals
ECG-AF: Identification of atrial fibrillation from sinus rhythm in recorded 1-lead ECG signals as verified by the gold standard 12-lead ECG interpretation, measured in the form of sensitivity, specificity, positive and negative predictive values, and accuracy.
Measured: Day 0
Differentiation of Atrial Fibrillation from Sinus Rhythm in PCG and 1-Lead ECG Signals
AUSC+ECG-AF: Identification of atrial fibrillation from sinus rhythm in PCG and 1-lead ECG signals as verified by the gold standard 12-lead ECG interpretation, measured in the form of sensitivity, specificity, positive and negative predictive values, and accuracy.
Measured: Day 0
Differentiation of Atrial Fibrillation from Sinus Rhythm in Facial Photoplethysmography Signals
rPPG-AF: Identification of atrial fibrillation from sinus rhythm in facial photoplethysmography signals (also known as remote photoplethysmography [rPPG]) as verified by the gold standard 12-lead ECG interpretation, measured in the form of sensitivity, specificity, positive and negative predictive values, and accuracy.
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start27 Aug 2025
- Primary completionAug 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial Fibrillation (AF)Studies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 209 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Laboratory of Data Discovery for Health
- Responsible party
- Principal investigator, Wong Chun Ka, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07154303
- Sponsor's protocol ID
- AUSC/ECG/rPPG-AF
- Other IDs
- UW 24-763
- Status last verified
- Dec 2025
- First submitted
- 26 Aug 2025
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartphone-Based Use of Phonocardiography, Electrocardiography Accessory, and/or Facial Photoplethysmography to Detect Atrial Fibrillation: Diagnostic Performance Study
- ClinicalTrials.gov ID
- NCT07154303
- Acronym / sponsor ID
- AUSC/ECG/rPPG-AF
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Smartphone, Persistent Atrial Fibrillation, Mobile Health, mHealth, Telemedicine, Artificial Intelligence, Heart Sounds, Phonocardiography
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 209 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Laboratory of Data Discovery for Health
- Study start
- 27 Aug 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 4 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this 4-in-1 observational study is to test the performance of artificial intelligences (AIs) in distinguishing irregularly irregular heart rhythm called atrial fibrillation (AF) from normal heart rhythm using physiological signals collected by smartphones' built-in hardware and/or external accessories.
Participants will:
- Have their weight, height, resting heart rate and blood pressures measured
- Have 12-lead electrocardiogram (ECG) of their heart electrical activities recorded
- Have their heart sounds and 1-lead ECG recorded from their chest, and optical-based blood flow data (photoplethysmography or PPG) and 1-lead ECG recorded from their fingers using smartphones' built-in microphone, camera, and/or external accessories
- Optionally have their optical-based blood flow data recorded from their face using smartphones' built-in camera (remote PPG or rPPG).
The researchers will also create a database containing the physiological signals collected in this study along with the participants' medically relevant information to help train and test future AIs for medical applications.
Detailed description
4 observational studies have been combined into 1 observational study to share the same pool of participants. These 4 studies are designated as AUSC-AF, ECG-AF, AUSC+ECG-AF, and rPPG-AF corresponding to the signal modality/modalities used for AF detection (see outcome measures) and designated as AUSC/ECG/rPPG-AF when combined as 1 study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atrial Fibrillation | – | Diagnostic Test: Computer algorithms |
| Sinus Rhythm | – | Diagnostic Test: Computer algorithms |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Hospital cardiology patients
Key inclusion criteria (5 listed)
- Age: ≥22 years (adult)
- Patients who have one of the following:
- Permanent atrial fibrillation, or
- Long-standing persistent atrial fibrillation (12 months or longer), or
- Confirmed 12-lead ECG diagnosis for persistent atrial fibrillation (> 7 days) or sinus rhythm within 12 months at the time of their normal attendance at the hospital
Key exclusion criteria (9 listed)
- Implanted active medical devices in the torso, such as pacemakers and defibrillators
- Patients without atrial fibrillation who have another arrhythmia
- Completely missing one or more limbs, or missing any hand
- Disability in using their hands or arms
- Lack of both index fingers, or all fingers in any hand
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer algorithmsAlso: ausculto®, Vitogram®, FacialAIComputer algorithms that are designed to perform heart sound, electrocardiography (ECG), and/or facial photoplethysmography (rPPG) analysis on data collected from smartphone's internal hardware and/or external accessories. | Diagnostic test | Atrial Fibrillation, Sinus Rhythm |
Primary outcome
Differentiation of Atrial Fibrillation from Sinus Rhythm in Heart Sound Recordings
Time frame: Day 0
AUSC-AF: Identification of atrial fibrillation (AF) from sinus rhythm in recorded heart sounds (phonocardiogram [PCG]) as verified by the gold standard 12-lead electrocardiography (ECG) interpretation, measured in the form of sensitivity and specificity.
4 secondary outcomes
Differentiation of Atrial Fibrillation from Sinus Rhythm in Heart Sound Recordings
Time frame: Day 0
Differentiation of Atrial Fibrillation from Sinus Rhythm in 1-Lead ECG Signals
Time frame: Day 0
Differentiation of Atrial Fibrillation from Sinus Rhythm in PCG and 1-Lead ECG Signals
Time frame: Day 0
Differentiation of Atrial Fibrillation from Sinus Rhythm in Facial Photoplethysmography Signals
Time frame: Day 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation (AF)
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
Atrial Fibrillation (AF)
Not yet recruitingObservational study
Hummingbird ICE Study
ATRIAL APPENDAGE CLOSURE for ATRIAL FIBRILLATION, Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF), run by The University of Hong Kong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differentiation of Atrial Fibrillation from Sinus Rhythm in Heart Sound Recordings (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.