Atrial Fibrillation (AF)GEMININCT06842147
Effectiveness of Artificial IntelliGence-Driven Single-LEad Long-TerM Electrocardiograms MonItoring in Detecting New-Diagnosed Atrial FIbrillation
A study testing 7-day single-lead long-term ECG monitoring device. and Standard Screening Group in people with Atrial Fibrillation (AF), run by Beijing Anzhen Hospital at 1 site in China.
Trial summary
Abstract Purpose: Atrial fibrillation (AF) is a leading cause of stroke and heart failure, yet detection remains suboptimal in rural settings due to limited resources. This study evaluates whether an enhanced screening strategy using artificial intelligence (AI)-integrated 7-day single-lead electrocardiogram (ECG)… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Atrial Fibrillation (AF)
- What is being tested?
- 7-day single-lead long-term ECG monitoring device. and Standard Screening Group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,360 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2025to 30 Jul 2028
- Phase
- Interventional
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 60 years or older No previous history of atrial fibrillation (AF) Willing to participate in random assignment and follow-up
Who cannot join
- Patients with a pacemaker or implanted cardioverter-defibrillator (ICD) Patients with cognitive impairment or unable to provide informed consent Patients with an estimated life expectancy of less than one year (e.g., advanced cancer or end-stage renal disease) Patients deemed unsuitable for the study by the investigator Patients who refuse to participate
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, 1 recruiting
- Recruiting
Beijing Anzhen Hospital
Zhejiang, Quzhou
Song Zuo, MD, +8618801427775, song_zuo@126.com
song_zuo@126.com
About this study
Abstract Purpose: Atrial fibrillation (AF) is a leading cause of stroke and heart failure, yet detection remains suboptimal in rural settings due to limited resources. This study evaluates whether an enhanced screening strategy using artificial intelligence (AI)-integrated 7-day single-lead electrocardiogram (ECG) patches improves AF detection and long-term clinical outcomes compared to routine care in rural China.
Methods: This cluster-randomized trial will be conducted across 128 village clinics in Quzhou, Zhejiang Province. Villages are randomized 1:1 to either enhanced or routine screening. Participants aged 60 years or older (approximately 120 per village) in both arms receive family-centered AF education and opportunistic assessments. The enhanced group undergoes screening via 7-day single-lead ECG patches, while the routine group utilizes standard 12-lead ECGs.
Read more
Results: The trial features two primary endpoints. The Phase 1 endpoint is the newly diagnosed AF detection rate during a 1-year screening period. The Phase 2 endpoint is a 3-year composite outcome of all-cause mortality, stroke or systemic embolism, and hospitalization for heart failure.
Conclusion: By integrating wearable AI technology into primary care, this trial seeks to overcome diagnostic barriers in resource-limited environments. The findings will determine if prolonged digital monitoring can significantly enhance AF detection and reduce major cardiovascular events in elderly rural populations.
Read the detailed description
Effectiveness of Artificial IntelliGence-Driven Single-Lead Long-Term Electrocardiograms Monitoring In Detecting New-Diagnosed Atrial FIbrillation (GEMINI) trial is a parallel, two-stage cluster randomized trial being conducted in 128 villages in Qujiang District, Quzhou City, Zhejiang Province. Village clinics serve as the primary health care units and provide essential services to rural residents, with one clinic allocated to each administrative village in China. Each village clinic is staffed by a village doctor with basic medical training (certificate-level) and operates under the supervision of physicians based at 8 township health centers. These township health centers are, in turn, overseen by a single district-level hospital, forming a three-tier hierarchical healthcare system . This decentralized structure, designed to address the shortage of specialist resources at the village level, enables consistent outreach and sustained medical engagement across rural populations. In this study, the villages (clusters) were randomly assigned to either the enhanced screening group (intervention arm) or the routine screening group (control arm). The coprimary outcomes are the 1-year detection rate of newly diagnosed AF (Phase 1) and a 3-year composite of all-cause mortality, stroke or systemic embolism, and hospitalization for heart failure (Phase 2).
- Conditions
- Atrial Fibrillation (AF)
- Being tested
- 7-day single-lead long-term ECG monitoring device., Standard Screening Group
- Keywords
- atrial fibrillation, patch
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
7-day single-lead long-term ECG monitoring device.Device
Participants in the long-term screening group will undergo baseline data collection and a 12-lead ECG at baseline, followed using a 7-day single-lead long-term ECG monitoring device. This device continuously collects dynamic ECG data for seven days and allows participants to view and store ECGs through the accompanying software (registration number: 20192070163).
Standard Screening GroupDevice
Patients in the standard screening group will undergo baseline data collection and a standard 12-lead ECG at the start of the study, with follow-up including opportunistic ECG checks as needed. Those diagnosed with AF will receive anticoagulation and antiarrhythmic therapy according to clinical guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Long-term Screening Group | Experimental | This group will use the 7-day single-lead ECG monitoring device, a standard 12-lead ECG, family-centered AF education and opportunistic screening. Receives: Device: 7-day single-lead long-term ECG monitoring device. |
| Standard Screening Group | Active comparator | This group will receive a standard 12-lead ECG, family-centered AF education and opportunistic screening. Receives: Device: Standard Screening Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate of new atrial fibrillation diagnoses
Detection rate of new atrial fibrillation diagnoses in both groups. Atrial fibrillation is defined by a single-lead ECG (≥30s) or a 12-lead ECG (≥10s) showing absent P waves, replaced by irregular fibrillation waves (f-waves) of varying size, shape, and duration, and absolute irregularity of RR intervals. Two cardiologists will interpret the ECG, and if there is doubt, a third cardiologist will review the case. Opportunistic ECG is defined as any ECG performed for medical reasons during follow-up (primarily 12-lead ECG), which must be reported and diagnosed.
Measured: 1 year
Composite endpoints
The all-cause mortality, stroke/systemic embolism, and heart failure hospitalization rate in the study population.
Measured: 3 years
Secondary outcomes (7)
Atrial Fibrillation Burden Assessment
Assessment of atrial fibrillation burden, defined by the duration and frequency of episodes, measured through continuous monitoring and ECG evaluations.
Measured: 1 year
All-Cause Mortality Rate
The all-cause mortality rate in the study population, measuring the number of participants who have died from any cause.
Measured: 3 years
Cardiovascular Mortality Rate
The cardiovascular mortality rate, defined as death directly caused by cardiovascular diseases, including acute myocardial infarction, heart failure, stroke, etc.
Measured: 3 years
Stroke/systemic embolism:
Stroke is defined as an acute episode of focal or global neurological dysfunction caused by intraparenchymal, intraventricular, or subarachnoid hemorrhage, or central nervous system infarction. Systemic embolism refers to a thrombus or other material traveling through the bloodstream and causing embolism in other vital organs (e.g., kidneys, limbs, etc.).
Measured: 3 years
Heart Failure Hospitalization Rate
The rate of hospitalization due to heart failure in the study population.
Measured: 3 years
Cardiovascular Hospitalization Rate
The rate of hospitalization due to cardiovascular events (excluding heart failure) in the study population.
Measured: 3 years
Detection Rate of New Atrial Fibrillation
The detection rate of new atrial fibrillation diagnoses during the study period, defined by the criteria set for ECG findings.
Measured: 3 years
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 start1 Mar 2025
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15,360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Anzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06842147
- Sponsor's protocol ID
- Beijing An Zhen Hospital
- Acronym
- GEMINI
- Status last verified
- Dec 2025
- First submitted
- 10 Feb 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Artificial IntelliGence-Driven Single-LEad Long-TerM Electrocardiograms MonItoring in Detecting New-Diagnosed Atrial FIbrillation
- ClinicalTrials.gov ID
- NCT06842147
- Acronym / sponsor ID
- GEMINI / Beijing An Zhen Hospital
- Conditions
- Atrial Fibrillation (AF)
- Keywords
- atrial fibrillation, patch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15,360 participants (estimated)
- Lead sponsor
- Beijing Anzhen HospitalUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (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.
Abstract Purpose: Atrial fibrillation (AF) is a leading cause of stroke and heart failure, yet detection remains suboptimal in rural settings due to limited resources. This study evaluates whether an enhanced screening strategy using artificial intelligence (AI)-integrated 7-day single-lead electrocardiogram (ECG) patches improves AF detection and long-term clinical outcomes compared to routine care in rural China.
Methods: This cluster-randomized trial will be conducted across 128 village clinics in Quzhou, Zhejiang Province. Villages are randomized 1:1 to either enhanced or routine screening. Participants aged 60 years or older (approximately 120 per village) in both arms receive family-centered AF education and opportunistic assessments. The enhanced group undergoes screening via 7-day single-lead ECG patches, while the routine group utilizes standard 12-lead ECGs.
Results: The trial features two primary endpoints. The Phase 1 endpoint is the newly diagnosed AF detection rate during a 1-year screening period. The Phase 2 endpoint is a 3-year composite outcome of all-cause mortality, stroke or systemic embolism, and hospitalization for heart failure.
Conclusion: By integrating wearable AI technology into primary care, this trial seeks to overcome diagnostic barriers in resource-limited environments. The findings will determine if prolonged digital monitoring can significantly enhance AF detection and reduce major cardiovascular events in elderly rural populations.
Detailed description
Effectiveness of Artificial IntelliGence-Driven Single-Lead Long-Term Electrocardiograms Monitoring In Detecting New-Diagnosed Atrial FIbrillation (GEMINI) trial is a parallel, two-stage cluster randomized trial being conducted in 128 villages in Qujiang District, Quzhou City, Zhejiang Province. Village clinics serve as the primary health care units and provide essential services to rural residents, with one clinic allocated to each administrative village in China. Each village clinic is staffed by a village doctor with basic medical training (certificate-level) and operates under the supervision of physicians based at 8 township health centers. These township health centers are, in turn, overseen by a single district-level hospital, forming a three-tier hierarchical healthcare system . This decentralized structure, designed to address the shortage of specialist resources at the village level, enables consistent outreach and sustained medical engagement across rural populations. In this study, the villages (clusters) were randomly assigned to either the enhanced screening group (intervention arm) or the routine screening group (control arm). The coprimary outcomes are the 1-year detection rate of newly diagnosed AF (Phase 1) and a 3-year composite of all-cause mortality, stroke or systemic embolism, and hospitalization for heart failure (Phase 2).
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long-term Screening Group | Experimental | Device: 7-day single-lead long-term ECG monitoring device.This group will use the 7-day single-lead ECG monitoring device, a standard 12-lead ECG, family-centered AF education and opportunistic screening. |
| Standard Screening Group | Active comparator | Device: Standard Screening GroupThis group will receive a standard 12-lead ECG, family-centered AF education and opportunistic screening. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 60 years or older No previous history of atrial fibrillation (AF) Willing to participate in random assignment and follow-up
Key exclusion criteria (1 listed)
- Patients with a pacemaker or implanted cardioverter-defibrillator (ICD) Patients with cognitive impairment or unable to provide informed consent Patients with an estimated life expectancy of less than one year (e.g., advanced cancer or end-stage renal disease) Patients deemed unsuitable for the study by the investigator Patients who refuse to participate
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 |
|---|---|---|
| 7-day single-lead long-term ECG monitoring device.Participants in the long-term screening group will undergo baseline data collection and a 12-lead ECG at baseline, followed using a 7-day single-lead long-term ECG monitoring device. This device continuously collects dynamic ECG data for seven days and allows participants to view and store ECGs through the accompanying software (registration number: 20192070163). | Device | Long-term Screening Group |
| Standard Screening GroupPatients in the standard screening group will undergo baseline data collection and a standard 12-lead ECG at the start of the study, with follow-up including opportunistic ECG checks as needed. Those diagnosed with AF will receive anticoagulation and antiarrhythmic therapy according to clinical guidelines. | Device | Standard Screening Group |
Primary outcome
Detection rate of new atrial fibrillation diagnoses
Time frame: 1 year
Detection rate of new atrial fibrillation diagnoses in both groups. Atrial fibrillation is defined by a single-lead ECG (≥30s) or a 12-lead ECG (≥10s) showing absent P waves, replaced by irregular fibrillation waves (f-waves) of varying size, shape, and duration, and absolute irregularity of RR intervals. Two cardiologists will interpret the ECG, and if there is doubt, a third cardiologist will review the case. Opportunistic ECG is defined as any ECG performed for medical reasons during follow-up (primarily 12-lead ECG), which must be reported and diagnosed.
Composite endpoints
Time frame: 3 years
The all-cause mortality, stroke/systemic embolism, and heart failure hospitalization rate in the study population.
7 secondary outcomes
Atrial Fibrillation Burden Assessment
Time frame: 1 year
All-Cause Mortality Rate
Time frame: 3 years
Cardiovascular Mortality Rate
Time frame: 3 years
Stroke/systemic embolism:
Time frame: 3 years
Heart Failure Hospitalization Rate
Time frame: 3 years
Cardiovascular Hospitalization Rate
Time frame: 3 years
Detection Rate of New Atrial Fibrillation
Time frame: 3 years
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 7 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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?
A study testing 7-day single-lead long-term ECG monitoring device. and Standard Screening Group in people with 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 1 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: looking for participants now, as of the sponsor's last update on 7 Jan 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detection rate of new atrial fibrillation diagnoses (time frame: 1 year). The study lists 2 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 7 Jan 2026.