Atrial Fibrillation (AF)Polaris-AFNCT06686940
Photoplethysmography (PPG) Algorithm With Smartwatch in Evaluation of Atrial Fibrillation Burden
An observational study of Atrial Fibrillation (AF), run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the monitoring effect of a smart electrocardiogram watch based on the PPG algorithm on atrial fibrillation burden. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- intervention group
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 30 Dec 2024to 30 Dec 2034
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients diagnosed with atrial fibrillation who meet age and health criteria can use electrocardiographic watches for long-term monitoring.
Who may be able to join
- Atrial fibrillation patients diagnosed by electrocardiogram
- Willing to use long-range electrocardiogram monitoring equipment
Who cannot join
- 1.Patients who are allergic to electronic devices or unable to wear watches
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100000
Song Zuo, M.D, 1880142775, song_zuo@126.com
About this study
The purpose of this study is to evaluate the monitoring effect of a smart electrocardiogram watch based on the PPG algorithm on atrial fibrillation burden.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- intervention group
- Keywords
- atrial fibrillation burden, Photoplethysmography, Wearable devices.
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intervention groupDevice
The monitoring effect of a smart electrocardiogram watch based on the PPG algorithm on atrial fibrillation burden.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
all-cause death, cardiovascular death, myocardial infarction, heart failure, stroke, peripheral vascular disease, recurrence of atrial fibrillation diagnosed by electrocardiogram, palpitations symptoms
Measured: December 30, 2024 to Decemberr 30, 2034
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2024
- Study start30 Dec 2024 (estimated)
- Primary completion30 Dec 2034 (estimated)
- Study completion30 Dec 2034 (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.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06686940
- Sponsor's protocol ID
- KS2024100
- Other IDs
- KS2024100
- Acronym
- Polaris-AF
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 13 Nov 2024
- 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 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photoplethysmography (PPG) Algorithm With Smartwatch in Evaluation of Atrial Fibrillation Burden
- ClinicalTrials.gov ID
- NCT06686940
- Acronym / sponsor ID
- Polaris-AF / KS2024100
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- atrial fibrillation burden, Photoplethysmography, Wearable devices.
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2034 (estimated)
- Study completion
- 30 Dec 2034 (estimated)
- First posted
- 13 Nov 2024 (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 study is to evaluate the monitoring effect of a smart electrocardiogram watch based on the PPG algorithm on atrial fibrillation burden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with atrial fibrillation who meet age and health criteria can use electrocardiographic watches for long-term monitoring.
Key inclusion criteria (2 listed)
- Atrial fibrillation patients diagnosed by electrocardiogram
- Willing to use long-range electrocardiogram monitoring equipment
Key exclusion criteria (1 listed)
- 1.Patients who are allergic to electronic devices or unable to wear watches
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 |
|---|---|---|
| intervention groupThe monitoring effect of a smart electrocardiogram watch based on the PPG algorithm on atrial fibrillation burden. | Device | – |
Primary outcome
Primary outcome
Time frame: December 30, 2024 to Decemberr 30, 2034
all-cause death, cardiovascular death, myocardial infarction, heart failure, stroke, peripheral vascular disease, recurrence of atrial fibrillation diagnosed by electrocardiogram, palpitations symptoms
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 13 Nov 2024.
- Individual participant dataSharing planned: No
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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.
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 Beijing Anzhen Hospital 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 2 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 Nov 2024. 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?
Contact Song Zuo, M.D (1880142775, song_zuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: December 30, 2024 to Decemberr 30, 2034). 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 13 Nov 2024; AzTrials last refreshed its copy on 26 Oct 2026.