Atrial Fibrillation (AF)AFRVRNCT07722039
Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
An observational study of Atrial Fibrillation (AF) and Atrial Fibrillation With Rapid Ventricular Response, run by HUINNO Co., Ltd.
Trial summary
The purpose of this retrospective study is to evaluate the clinical performance of SMD-RVECG, an artificial intelligence-based medical device software that analyzes single-lead electrocardiogram data to predict the risk of atrial fibrillation with rapid ventricular response occurring within 2 hours. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Atrial Fibrillation (AF), Atrial Fibrillation With Rapid Ventricular Response
- What is being tested?
- SMD-RVECG
- Type of treatment
- Medical device
- How many people
- 348 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged 19 years or older whose continuous single-lead electrocardiogram data were collected through VitalDB at Seoul National University Hospital between September 1, 2022, and September 30, 2025. The study population includes patients with atrial fibrillation whose eligible electrocardiogram datasets are classified according to the presence or absence of rapid ventricular response. AF with RVR-positive datasets include atrial fibrillation followed by rapid ventricular response, defined as an average heart rate of 110 beats per minute or greater for at least 30 seconds. AF with RVR-negative datasets include atrial fibrillation without rapid ventricular response during the predefined assessment period.
Who may be able to join
- Continuous single-lead electrocardiogram data collected through VitalDB at Seoul National University Hospital between September 1, 2022, and September 30, 2025
- Participant aged 19 years or older at the time of electrocardiogram data collection
- Electrocardiogram data meeting either of the following group definitions:
- AF with RVR-positive group: atrial fibrillation followed by rapid ventricular response, defined as an average heart rate of 110 beats per minute or greater for at least 30 seconds, with available electrocardiogram data for up to 2 hours before the onset of rapid ventricular response and after the onset in accordance with the protocol
- AF with RVR-negative group: atrial fibrillation without rapid ventricular response, with 3 hours of electrocardiogram data available before a selected index time corresponding to a similar time during hospitalization as that used for positive cases
- If the relevant episode occurred within 2 hours after the start of electrocardiogram recording, availability of electrocardiogram data from the start of recording through up to 1 hour after the episode, with a minimum electrocardiogram recording duration of 10 minutes
- Other data considered suitable for the study by the principal investigator
Who cannot join
- Electrocardiogram data considered to be of inadequate quality because of noise, poor equipment handling, unclear signals, artifacts, or similar problems
- Electrocardiogram data with signal loss of 5 percent or greater
- Electrocardiogram data with a heart rate below 30 beats per minute or above 300 beats per minute
- Data collected from a participant who was pregnant or breastfeeding at the time of data collection
- Data previously used for training or validation of the artificial intelligence model
- Electrocardiogram data from a participant whose baseline heart rate remained at 110 beats per minute or greater irrespective of atrial fibrillation
- Data considered unsuitable for this clinical study by the principal investigator
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Retrospective, Single Center, Single Arm, Superiority Confirmatory Study to Evaluate the Clinical Validity of SMD-RVECG, Artificial Intelligence Software to Predict the Risk of Developing Atrial Fibrillation With Rapid Ventricular Response (AF With RVR) Within 2 Hours Using Single Lead-Based Electrocardiogram Analysis
The purpose of this retrospective study is to evaluate the clinical performance of SMD-RVECG, an artificial intelligence-based medical device software that analyzes single-lead electrocardiogram data to predict the risk of atrial fibrillation with rapid ventricular response occurring within 2 hours.
A total of 348 eligible electrocardiogram datasets collected through VitalDB at Seoul National University Hospital will be included. Atrial fibrillation with rapid ventricular response is defined in this study as atrial fibrillation accompanied by an average heart rate of 110 beats per minute or greater for at least 30 seconds.
Eligible datasets will be classified as positive or negative for atrial fibrillation with rapid ventricular response. Two qualified physicians blinded to the software results will review the electrocardiogram data and relevant medical records to establish the reference-standard classification. The blinded electrocardiogram datasets will then be analyzed using SMD-RVECG, and the software-generated predictions will be compared with the reference standard to evaluate clinical performance.
Read the detailed description
This clinical study is designed as a retrospective, single-center, single-arm, superiority confirmatory clinical performance study conducted at Seoul National University Hospital.
Pre-screening Electronic medical records and the VitalDB registry will be reviewed to identify potentially eligible data. The study will use continuous single-lead electrocardiogram data collected through VitalDB between September 1, 2022, and September 30, 2025, from patients who were 19 years of age or older at the time of data collection.
Screening and Data Collection A screening number will be assigned sequentially to each potentially eligible dataset. Eligibility will be determined by reviewing the predefined inclusion and exclusion criteria. For eligible cases, continuous single-lead electrocardiogram data, signal loss, heart rate, the occurrence and timing of atrial fibrillation with rapid ventricular response episodes, the electrocardiogram data collection period, demographic information, previous history of atrial fibrillation, and pregnancy status will be collected. Directly identifying personal information will not be collected.
Test Dataset Creation Eligible electrocardiogram datasets will be classified into positive and negative groups for atrial fibrillation with rapid ventricular response.
The positive group will include electrocardiogram datasets in which atrial fibrillation is followed by rapid ventricular response, defined as an average heart rate of 110 beats per minute or greater for at least 30 seconds. The dataset will include electrocardiogram data preceding the onset of rapid ventricular response and data following the episode, as specified in the study protocol.
The negative group will include electrocardiogram datasets with atrial fibrillation that is not accompanied by rapid ventricular response during the predefined assessment period.
The planned study dataset consists of 348 cases, including 58 positive cases and 290 negative cases.
Reference Standard Establishment Two anesthesiology and pain medicine specialists with at least 5 years of relevant clinical experience in electrocardiogram-based arrhythmia interpretation will independently review the electrocardiogram data and relevant medical records. The reviewers will assess electrocardiogram data quality, confirm the presence or absence and timing of atrial fibrillation with rapid ventricular response, and establish the reference-standard classification.
The reviewers will be blinded to each other's initial assessments and to the results generated by SMD-RVECG. If the two reviewers disagree, the classification will be determined through consensus and the basis for the consensus will be documented. If consensus cannot be reached, the dataset will be excluded from the study.
Application of the Investigational Device The medical device operator will receive the test electrocardiogram datasets identified only by screening numbers and will be blinded to the positive or negative reference-standard classifications. The datasets will be retrospectively analyzed using SMD-RVECG to generate risk estimates for atrial fibrillation with rapid ventricular response occurring within 2 hours. The software-generated peak risk values and corresponding times will be recorded.
Statistical Analysis The software-generated predictions will be compared with the reference-standard classifications. The primary performance measure is the area under the receiver operating characteristic curve for predicting atrial fibrillation with rapid ventricular response within 2 hours. A two-sided 95% confidence interval will be calculated using Newcombe's Wald method. The study will be considered successful if the lower bound of the 95% confidence interval is greater than 0.8.
Secondary performance measures include the area under the precision-recall curve, threshold-specific precision, recall, F1 score, sensitivity, specificity, positive predictive value, negative predictive value, confusion-matrix results, and prediction time horizon.
Because this retrospective study uses previously collected data, there will be no direct participant contact, additional examination, treatment, or change in clinical care.
- Being tested
- SMD-RVECG
- Keywords
- Atrial Fibrillation With Rapid Ventricular Response, AF With RVR, Rapid Ventricular Response, Atrial Fibrillation Prediction, Single-Lead Electrocardiogram, Artificial Intelligence, Software as a Medical Device, SMD-RVECG
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMD-RVECGDevice
SMD-RVECG is an artificial intelligence-based software as a medical device designed to analyze continuous single-lead electrocardiogram data and estimate the risk of atrial fibrillation with rapid ventricular response occurring within 2 hours. The software generates a risk score ranging from 0 to 100 based on electrocardiogram signal characteristics.
In this retrospective study, blinded electrocardiogram datasets identified only by screening numbers will be analyzed using SMD-RVECG. The software-generated risk scores, peak values, and corresponding times will be recorded and compared with the reference-standard classifications. The software will not be used to guide the clinical care of the patients whose data are included.
| Study group | Role | What they receive |
|---|---|---|
| AF With RVR Positive Group | Electrocardiogram datasets from patients with atrial fibrillation in which rapid ventricular response occurred. Rapid ventricular response is defined as an average heart rate of 110 beats per minute or greater for at least 30 seconds. The dataset includes electrocardiogram data preceding the first onset of rapid ventricular response and data following the episode in accordance with the protocol. These datasets will be retrospectively analyzed using SMD-RVECG. Receives: Device: SMD-RVECG | |
| AF With RVR Negative Group | Electrocardiogram datasets from patients with atrial fibrillation in which rapid ventricular response did not occur during the predefined assessment period. The dataset includes electrocardiogram data from the 3 hours preceding a selected index time corresponding to a similar time during hospitalization as the onset time used for positive cases. These datasets will be retrospectively analyzed using SMD-RVECG. Receives: Device: SMD-RVECG |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUROC of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
The area under the receiver operating characteristic curve (AUROC) will be calculated by comparing the maximum risk score generated by SMD-RVECG with the reference-standard classification of the AF with RVR-positive and AF with RVR-negative electrocardiogram datasets. Sensitivity and the false-positive rate will be calculated across the evaluated decision thresholds to construct the receiver operating characteristic curve. A two-sided 95% confidence interval will be estimated using Newcombe's Wald method. The performance criterion will be met if the lower bound of the 95% confidence interval is greater than 0.8.
Measured: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Secondary outcomes (7)
Area Under the Precision-Recall Curve of SMD-RVECG
The area under the precision-recall curve (AUPRC) will be calculated using the risk scores generated by SMD-RVECG and the reference-standard classification of the AF with RVR-positive and AF with RVR-negative electrocardiogram datasets. A higher AUPRC indicates better discrimination of AF with RVR-positive datasets.
Measured: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Sensitivity of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response
Sensitivity, also referred to as recall, will be calculated at the evaluated decision thresholds as the proportion of reference-standard AF with RVR-positive datasets that are classified as positive by SMD-RVECG.
Measured: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Specificity of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response
Specificity will be calculated at the evaluated decision thresholds as the proportion of reference-standard AF with RVR-negative datasets that are classified as negative by SMD-RVECG.
Measured: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Positive Predictive Value of SMD-RVECG
Positive predictive value, also referred to as precision, will be calculated at the evaluated decision thresholds as the proportion of datasets classified as positive by SMD-RVECG that are AF with RVR-positive according to the reference standard.
Measured: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Negative Predictive Value of SMD-RVECG
Negative predictive value will be calculated at the evaluated decision thresholds as the proportion of datasets classified as negative by SMD-RVECG that are AF with RVR-negative according to the reference standard.
Measured: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
F1 Score of SMD-RVECG
The F1 score will be calculated at the evaluated decision thresholds as the harmonic mean of precision and recall. The F1 score ranges from 0 to 1, with higher values indicating a better balance between precision and recall.
Measured: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Prediction Time Horizon of SMD-RVECG for Atrial Fibrillation With Rapid Ventricular Response
For AF with RVR-positive datasets, the prediction time horizon will be calculated as the time interval between the software-generated prediction or alarm and the reference-standard onset of the AF with RVR episode.
Measured: Within the 2-hour period preceding the onset of atrial fibrillation with rapid ventricular response
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 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.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 348 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HUINNO Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Korea Medical Device Development Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722039
- Sponsor's protocol ID
- HU-AFRVR-01
- Other IDs
- RS-2026-25543193
- Acronym
- AFRVR
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No: Individual participant data collected in this study are not planned to be shared with external researchers. Any future sharing would require separate sponsor approval and compliance with applicable privacy, ethical, and institutional requirements.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective, Single Center, Single Arm, Superiority Confirmatory Study to Evaluate the Clinical Validity of SMD-RVECG, Artificial Intelligence Software to Predict the Risk of Developing Atrial Fibrillation With Rapid Ventricular Response (AF With RVR) Within 2 Hours Using Single Lead-Based Electrocardiogram Analysis
- ClinicalTrials.gov ID
- NCT07722039
- Acronym / sponsor ID
- AFRVR / HU-AFRVR-01
- Keywords
- Atrial Fibrillation With Rapid Ventricular Response, AF With RVR, Rapid Ventricular Response, Atrial Fibrillation Prediction, Single-Lead Electrocardiogram, Artificial Intelligence, Software as a Medical Device, SMD-RVECG
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 348 participants (estimated)
- Lead sponsor
- HUINNO Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Seoul National University Hospital, Korea Medical Device Development Fund
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 23 Jul 2026 (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 retrospective study is to evaluate the clinical performance of SMD-RVECG, an artificial intelligence-based medical device software that analyzes single-lead electrocardiogram data to predict the risk of atrial fibrillation with rapid ventricular response occurring within 2 hours.
A total of 348 eligible electrocardiogram datasets collected through VitalDB at Seoul National University Hospital will be included. Atrial fibrillation with rapid ventricular response is defined in this study as atrial fibrillation accompanied by an average heart rate of 110 beats per minute or greater for at least 30 seconds.
Eligible datasets will be classified as positive or negative for atrial fibrillation with rapid ventricular response. Two qualified physicians blinded to the software results will review the electrocardiogram data and relevant medical records to establish the reference-standard classification. The blinded electrocardiogram datasets will then be analyzed using SMD-RVECG, and the software-generated predictions will be compared with the reference standard to evaluate clinical performance.
Detailed description
This clinical study is designed as a retrospective, single-center, single-arm, superiority confirmatory clinical performance study conducted at Seoul National University Hospital.
Pre-screening Electronic medical records and the VitalDB registry will be reviewed to identify potentially eligible data. The study will use continuous single-lead electrocardiogram data collected through VitalDB between September 1, 2022, and September 30, 2025, from patients who were 19 years of age or older at the time of data collection.
Screening and Data Collection A screening number will be assigned sequentially to each potentially eligible dataset. Eligibility will be determined by reviewing the predefined inclusion and exclusion criteria. For eligible cases, continuous single-lead electrocardiogram data, signal loss, heart rate, the occurrence and timing of atrial fibrillation with rapid ventricular response episodes, the electrocardiogram data collection period, demographic information, previous history of atrial fibrillation, and pregnancy status will be collected. Directly identifying personal information will not be collected.
Test Dataset Creation Eligible electrocardiogram datasets will be classified into positive and negative groups for atrial fibrillation with rapid ventricular response.
The positive group will include electrocardiogram datasets in which atrial fibrillation is followed by rapid ventricular response, defined as an average heart rate of 110 beats per minute or greater for at least 30 seconds. The dataset will include electrocardiogram data preceding the onset of rapid ventricular response and data following the episode, as specified in the study protocol.
The negative group will include electrocardiogram datasets with atrial fibrillation that is not accompanied by rapid ventricular response during the predefined assessment period.
The planned study dataset consists of 348 cases, including 58 positive cases and 290 negative cases.
Reference Standard Establishment Two anesthesiology and pain medicine specialists with at least 5 years of relevant clinical experience in electrocardiogram-based arrhythmia interpretation will independently review the electrocardiogram data and relevant medical records. The reviewers will assess electrocardiogram data quality, confirm the presence or absence and timing of atrial fibrillation with rapid ventricular response, and establish the reference-standard classification.
The reviewers will be blinded to each other's initial assessments and to the results generated by SMD-RVECG. If the two reviewers disagree, the classification will be determined through consensus and the basis for the consensus will be documented. If consensus cannot be reached, the dataset will be excluded from the study.
Application of the Investigational Device The medical device operator will receive the test electrocardiogram datasets identified only by screening numbers and will be blinded to the positive or negative reference-standard classifications. The datasets will be retrospectively analyzed using SMD-RVECG to generate risk estimates for atrial fibrillation with rapid ventricular response occurring within 2 hours. The software-generated peak risk values and corresponding times will be recorded.
Statistical Analysis The software-generated predictions will be compared with the reference-standard classifications. The primary performance measure is the area under the receiver operating characteristic curve for predicting atrial fibrillation with rapid ventricular response within 2 hours. A two-sided 95% confidence interval will be calculated using Newcombe's Wald method. The study will be considered successful if the lower bound of the 95% confidence interval is greater than 0.8.
Secondary performance measures include the area under the precision-recall curve, threshold-specific precision, recall, F1 score, sensitivity, specificity, positive predictive value, negative predictive value, confusion-matrix results, and prediction time horizon.
Because this retrospective study uses previously collected data, there will be no direct participant contact, additional examination, treatment, or change in clinical care.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AF With RVR Positive Group | – | Device: SMD-RVECGElectrocardiogram datasets from patients with atrial fibrillation in which rapid ventricular response occurred. Rapid ventricular response is defined as an average heart rate of 110 beats per minute or greater for at least 30 seconds. The dataset includes electrocardiogram data preceding the first onset of rapid ventricular response and data following the episode in accordance with the protocol. These datasets will be retrospectively analyzed using SMD-RVECG. |
| AF With RVR Negative Group | – | Device: SMD-RVECGElectrocardiogram datasets from patients with atrial fibrillation in which rapid ventricular response did not occur during the predefined assessment period. The dataset includes electrocardiogram data from the 3 hours preceding a selected index time corresponding to a similar time during hospitalization as the onset time used for positive cases. These datasets will be retrospectively analyzed using SMD-RVECG. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 19 years or older whose continuous single-lead electrocardiogram data were collected through VitalDB at Seoul National University Hospital between September 1, 2022, and September 30, 2025. The study population includes patients with atrial fibrillation whose eligible electrocardiogram datasets are classified according to the presence or absence of rapid ventricular response. AF with RVR-positive datasets include atrial fibrillation followed by rapid ventricular response, defined as an average heart rate of 110 beats per minute or greater for at least 30 seconds. AF with RVR-negative datasets include atrial fibrillation without rapid ventricular response during the predefined assessment period.
Key inclusion criteria (7 listed)
- Continuous single-lead electrocardiogram data collected through VitalDB at Seoul National University Hospital between September 1, 2022, and September 30, 2025
- Participant aged 19 years or older at the time of electrocardiogram data collection
- Electrocardiogram data meeting either of the following group definitions:
- If the relevant episode occurred within 2 hours after the start of electrocardiogram recording, availability of electrocardiogram data from the start of recording through up to 1 hour after the episode, with a minimum electrocardiogram recording duration of 10 minutes
- Other data considered suitable for the study by the principal investigator
Key exclusion criteria (7 listed)
- Electrocardiogram data considered to be of inadequate quality because of noise, poor equipment handling, unclear signals, artifacts, or similar problems
- Electrocardiogram data with signal loss of 5 percent or greater
- Electrocardiogram data with a heart rate below 30 beats per minute or above 300 beats per minute
- Data collected from a participant who was pregnant or breastfeeding at the time of data collection
- Data previously used for training or validation of the artificial intelligence model
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 |
|---|---|---|
| SMD-RVECGSMD-RVECG is an artificial intelligence-based software as a medical device designed to analyze continuous single-lead electrocardiogram data and estimate the risk of atrial fibrillation with rapid ventricular response occurring within 2 hours. The software generates a risk score ranging from 0 to 100 based on electrocardiogram signal characteristics. In this retrospective study, blinded electrocardiogram datasets identified only by screening numbers will be analyzed using SMD-RVECG. The software-generated risk scores, peak values, and corresponding times will be recorded and compared with the reference-standard classifications. The software will not be used to guide the clinical care of the patients whose data are included. | Device | AF With RVR Negative Group, AF With RVR Positive Group |
Primary outcome
AUROC of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
The area under the receiver operating characteristic curve (AUROC) will be calculated by comparing the maximum risk score generated by SMD-RVECG with the reference-standard classification of the AF with RVR-positive and AF with RVR-negative electrocardiogram datasets. Sensitivity and the false-positive rate will be calculated across the evaluated decision thresholds to construct the receiver operating characteristic curve. A two-sided 95% confidence interval will be estimated using Newcombe's Wald method. The performance criterion will be met if the lower bound of the 95% confidence interval is greater than 0.8.
7 secondary outcomes
Area Under the Precision-Recall Curve of SMD-RVECG
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Sensitivity of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Specificity of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Positive Predictive Value of SMD-RVECG
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Negative Predictive Value of SMD-RVECG
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
F1 Score of SMD-RVECG
Time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours
Prediction Time Horizon of SMD-RVECG for Atrial Fibrillation With Rapid Ventricular Response
Time frame: Within the 2-hour period preceding the onset of atrial fibrillation with rapid ventricular response
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 23 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data collected in this study are not planned to be shared with external researchers. Any future sharing would require separate sponsor approval and compliance with applicable privacy, ethical, and institutional requirements.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation (AF) and Atrial Fibrillation With Rapid Ventricular Response, run by HUINNO Co., Ltd.
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 7 inclusion and 7 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 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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 JooYeon Yoo (+82-2-2051-3161, clinical_trial@huinno.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUROC of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours (time frame: During retrospective analysis of the predefined electrocardiogram dataset for each case, up to 3 hours). 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 23 Jul 2026.