Atrial Fibrillation (AF)Polaris-AFCANCT06842160
Photoplethysmography (PPG) Algorithm with Smartwatch in Evaluation of Atrial Fibrillation Burden After Catheter Ablation
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 effectiveness of a smart electrocardiogram watch based on the PPG algorithm in monitoring the atrial fibrillation burden of patients after catheter ablation. 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 Mar 2025to 30 Mar 2036
- 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 who have undergone catheter ablation for atrial fibrillation and meet age and health standards are able to use electrocardiographic watches for long-term monitoring
Who may be able to join
- Atrial fibrillation patients diagnosed by electrocardiogram
- Received catheter ablation procedure
- 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 effectiveness of a smart electrocardiogram watch based on the PPG algorithm in monitoring the atrial fibrillation burden of patients after catheter ablation.
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- intervention group
- Keywords
- Atrial Fibrillation Burden、 Catheter Ablation, 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
A smart electrocardiogram watch based on the PPG algorithm for monitoring atrial fibrillation load after catheter ablation.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Stroke
The rate of stroke occurrences in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of strokes per participant).
Measured: March 30, 2025 to March 30, 2035
Incidence of Heart Failure
The rate of heart failure occurrences in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of heart failure episodes per participant).
Measured: March 30, 2025 to March 30, 2035
All-Cause Mortality Rate
The rate of all-cause mortality in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of deaths per participant).
Measured: March 30, 2025 to March 30, 2035
Cardiovascular Mortality Rate
The rate of cardiovascular-related mortality in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of cardiovascular-related deaths per participant).
Measured: March 30, 2025 to March 30, 2035
Rate of Rehospitalization
The rate of rehospitalization due to any medical cause in the study population. The unit of measure will be the frequency of events (e.g., number of rehospitalization events per participant).
Measured: March 30, 2025 to March 30, 2035
Incidence of Bleeding Events
The rate of bleeding events (such as major or minor bleeding) in the study population. The unit of measure will be the frequency of events (e.g., number of bleeding events per participant).
Measured: March 30, 2025 to March 30, 2035
Postoperative Atrial Fibrillation Burden
The frequency and severity of atrial fibrillation episodes observed in participants after a surgical procedure, measured using data collected by an intelligent heart rate monitoring watch utilizing a PPG algorithm. The unit of measure will be frequency of events (e.g., number of episodes per participant).
Measured: March 30, 2025 to March 30, 2035
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start30 Mar 2025 (estimated)
- Primary completion30 Mar 2035 (estimated)
- Study completion30 Mar 2036 (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 Beijing Anzhen HospitalThe 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
- 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
- NCT06842160
- Sponsor's protocol ID
- KS2024101
- Other IDs
- KS2024101
- Acronym
- Polaris-AFCA
- Status last verified
- Feb 2025
- First submitted
- 4 Dec 2024
- Last updated
- 24 Feb 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 24 Feb 2025. 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 After Catheter Ablation
- ClinicalTrials.gov ID
- NCT06842160
- Acronym / sponsor ID
- Polaris-AFCA / KS2024101
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- Atrial Fibrillation Burden、 Catheter Ablation, 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 Mar 2025 (estimated)
- Primary completion
- 30 Mar 2035 (estimated)
- Study completion
- 30 Mar 2036 (estimated)
- First posted
- 24 Feb 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 study is to evaluate the effectiveness of a smart electrocardiogram watch based on the PPG algorithm in monitoring the atrial fibrillation burden of patients after catheter ablation.
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 who have undergone catheter ablation for atrial fibrillation and meet age and health standards are able to use electrocardiographic watches for long-term monitoring
Key inclusion criteria (3 listed)
- Atrial fibrillation patients diagnosed by electrocardiogram
- Received catheter ablation procedure
- 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 groupA smart electrocardiogram watch based on the PPG algorithm for monitoring atrial fibrillation load after catheter ablation. | Device | – |
Primary outcome
Incidence of Stroke
Time frame: March 30, 2025 to March 30, 2035
The rate of stroke occurrences in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of strokes per participant).
Incidence of Heart Failure
Time frame: March 30, 2025 to March 30, 2035
The rate of heart failure occurrences in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of heart failure episodes per participant).
All-Cause Mortality Rate
Time frame: March 30, 2025 to March 30, 2035
The rate of all-cause mortality in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of deaths per participant).
Cardiovascular Mortality Rate
Time frame: March 30, 2025 to March 30, 2035
The rate of cardiovascular-related mortality in the study population, measured separately for each participant. The unit of measure will be the frequency of events (e.g., number of cardiovascular-related deaths per participant).
Rate of Rehospitalization
Time frame: March 30, 2025 to March 30, 2035
The rate of rehospitalization due to any medical cause in the study population. The unit of measure will be the frequency of events (e.g., number of rehospitalization events per participant).
Incidence of Bleeding Events
Time frame: March 30, 2025 to March 30, 2035
The rate of bleeding events (such as major or minor bleeding) in the study population. The unit of measure will be the frequency of events (e.g., number of bleeding events per participant).
Postoperative Atrial Fibrillation Burden
Time frame: March 30, 2025 to March 30, 2035
The frequency and severity of atrial fibrillation episodes observed in participants after a surgical procedure, measured using data collected by an intelligent heart rate monitoring watch utilizing a PPG algorithm. The unit of measure will be frequency of events (e.g., number of episodes per participant).
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 24 Feb 2025.
- Individual participant dataSharing planned: No
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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.
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 3 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 24 Feb 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?
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?
Incidence of Stroke (time frame: March 30, 2025 to March 30, 2035). The study lists 7 primary outcomes in all. 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 24 Feb 2025.