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Atrial Fibrillation ParoxysmalPROVISION-AFNCT05725187

Prospective Validation Study of AI-based Prediction Algorithm for the Prediction of Paroxysmal Atrial Fibrillation

An observational study of Atrial Fibrillation Paroxysmal, run by Ewha Womans University Mokdong Hospital at 11 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to predict the occurrence of paroxysmal atrial fibrillation by finding high-risk group from normal sinus rhythm ECG through artificial intelligence-based prediction algorithm. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Atrial Fibrillation Paroxysmal
What is being tested?
MobiCare
Type of treatment
Medical device
How many people
600 participants
Where
11 sitesSouth Korea
Study dates
14 Oct 2022to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants are selected from adults above age of 20 with their consent with a target for patients who come to the hospital with arrhythmia symptoms from an outpatient clinic or who are admitted to a hospital.

Who may be able to join

  • Participants must be above 20 in age
  • Participants are patients with symptom of arrhythmia who visited outpatient clinic or who have been hospitalized

Who cannot join

  • Excluding patients with cardiac implantable electronic device such as pacemakers, implantable defibrillators (ICD), or cardiac resynchronization therapy (CRT).
  • Excluding pregnant women and lactating women.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

South Korea11 sites

  • Chonnam National University Hospital

    Gwangju, 61469

  • Yongin Severance Hospital

    Gyeonggi-do, 16995

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Chungbuk National University Hospital

    Jungbuk, 28644

  • Kyung Hee University Hospital

    Seoul, 02447

  • Korea University Anam Hospital

    Seoul, 02841

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Chung-Ang University Hospital

    Seoul, 06973

  • Ewha Womans University Seoul Hospital

    Seoul, 07804

  • Ewha Womans University Mokdong Hospital

    Seoul, 07985

  • Korea University Guro Hospital

    Seoul, 08308

Other trials in South Korea

About this study

Official title: Prospective Validation Study of Artificial Intelligence-based Prediction Algorithm for the Prediction of Paroxysmal Atrial Fibrillation

The purpose of this study is to predict the occurrence of paroxysmal atrial fibrillation by finding high-risk group from normal sinus rhythm ECG through artificial intelligence-based prediction algorithm.

Read the detailed description

This study is a multi-center, prospective observational validation study. Patients aged 18 or above who are hospitalized at our hospital or who visited the outpatient clinic with arrhythmia symptoms (such as palpitation) after the clinical research approval will be enrolled. The normal sinus rhythm electrocardiogram (ECG) at the time of participation in the study is recorded and put into the artificial intelligence prediction algorithm. The result of risk stratification is blinded and will not be informed to both the research director and subjects. After applying wearable devices to the subject, the ECG recorded for the first week is analyzed to confirm the occurrence of paroxysmal atrial fibrillation (the gold standard for diagnosis of atrial fibrillation). When the wearable devices are removed, the 12 lead electrocardiogram will be taken again, and if it shows normal sinus rhythm electrocardiogram, then it will be put into the artificial intelligence prediction algorithm to calculate the result as well.

Being tested
MobiCare
Keywords
artificial intelligence, electrocardiogram
Medical subject headings
Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MobiCareDevice

    It is a 9.2g wearable electrocardiogram device, mobiCARE, in the form of a patch, and the model name is MC200M.

Study groups in NCT05725187
Study groupRoleWhat they receive
Low risk group for paroxysmal atrial fibrillationSubject patients are above 20 in age who are hospitalized in our hospital or outpatients with arrhythmia symptoms after the clinical research approval. The sinus rhythm electrocardiogram at the time of the patient's participation in the study is put into the artificial intelligence prediction algorithm, and the risk stratification results are blinded and are not informed to both the research director and the subjects. For the low-risk group, after attaching the wearable electrocardiogram to the subject, the electrocardiogram recorded a week later is analyzed to confirm the occurrence of atrial fibrillation.
Receives: Device: MobiCare
High risk group for paroxysmal atrial fibrillationSubject patients are above 20 in age who are hospitalized in our hospital or outpatients with arrhythmia symptoms after the clinical research approval. The sinus rhythm electrocardiogram at the time of the patient's participation in the study is put into the artificial intelligence prediction algorithm, and the risk stratification results are blinded and are not informed to both the research director and the subjects. For the highrisk group, after attaching the wearable electrocardiogram to the subject, the electrocardiogram recorded a week later is analyzed to confirm the occurrence of atrial fibrillation.
Receives: Device: MobiCare

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of paroxysmal AF

    The AI prediction algorithm classifies patients into high-risk and low-risk categories for predicting paroxysmal atrial fibrillation within a week, based on ECG recordings of those with normal sinus rhythm. The accuracy of the prediction will be assessed through the use of a wearable device that records occurrence of paroxysmal atrial fibrillation over the course of a week.

    Measured: 1 week

Secondary outcomes (1)

  1. Performance verification of AI prediction model

    The artificial intelligence prediction algorithm categorizes patients into high-risk and low-risk groups when predicting paroxysmal atrial fibrillation within one week based on normal sinus rhythm ECG data. The AI prediction algorithm's performance is assessed based on the data obtained from the primary outcome, which involves confirming whether atrial fibrillation recorded through a week-long use of a wearable device. We will gauge the algorithm's effectiveness by evaluating its predictive abilities, encompassing sensitivity, specificity, positive predictive rate, negative predictive rate, and the F1 score.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2023
  2. Study start14 Oct 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05725187
Sponsor's protocol ID
PROVISION-AF
Acronym
PROVISION-AF
Status last verified
Sep 2024
First submitted
20 Jan 2023
Last updated
26 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ribeiro AH, Ribeiro MH, Paixao GMM, Oliveira DM, Gomes PR, Canazart JA, Ferreira MPS, Andersson CR, Macfarlane PW, Meira W Jr, Schon TB, Ribeiro ALP. Automatic diagnosis of the 12-lead ECG using a deep neural network. Nat Commun. 2020 Apr 9;11(1):1760. doi: 10.1038/s41467-020-15432-4.

    PubMed 32273514

  • Willems S, Borof K, Brandes A, Breithardt G, Camm AJ, Crijns HJGM, Eckardt L, Gessler N, Goette A, Haegeli LM, Heidbuchel H, Kautzner J, Ng GA, Schnabel RB, Suling A, Szumowski L, Themistoclakis S, Vardas P, van Gelder IC, Wegscheider K, Kirchhof P. Systematic, early rhythm control strategy for atrial fibrillation in patients with or without symptoms: the EAST-AFNET 4 trial. Eur Heart J. 2022 Mar 21;43(12):1219-1230. doi: 10.1093/eurheartj/ehab593.

    PubMed 34447995

  • Park J, Shim J, Lee JM, Park JK, Heo J, Chang Y, Song TJ, Kim DH, Lee HA, Yu HT, Kim TH, Uhm JS, Kim YD, Nam HS, Joung B, Lee MH, Heo JH, Pak HN; RAFAS Investigators*. Risks and Benefits of Early Rhythm Control in Patients With Acute Strokes and Atrial Fibrillation: A Multicenter, Prospective, Randomized Study (the RAFAS Trial). J Am Heart Assoc. 2022 Feb;11(3):e023391. doi: 10.1161/JAHA.121.023391. Epub 2022 Jan 19.

    PubMed 35043663

  • Noseworthy PA, Attia ZI, Behnken EM, Giblon RE, Bews KA, Liu S, Gosse TA, Linn ZD, Deng Y, Yin J, Gersh BJ, Graff-Radford J, Rabinstein AA, Siontis KC, Friedman PA, Yao X. Artificial intelligence-guided screening for atrial fibrillation using electrocardiogram during sinus rhythm: a prospective non-randomised interventional trial. Lancet. 2022 Oct 8;400(10359):1206-1212. doi: 10.1016/S0140-6736(22)01637-3. Epub 2022 Sep 27.

    PubMed 36179758

  • Attia ZI, Noseworthy PA, Lopez-Jimenez F, Asirvatham SJ, Deshmukh AJ, Gersh BJ, Carter RE, Yao X, Rabinstein AA, Erickson BJ, Kapa S, Friedman PA. An artificial intelligence-enabled ECG algorithm for the identification of patients with atrial fibrillation during sinus rhythm: a retrospective analysis of outcome prediction. Lancet. 2019 Sep 7;394(10201):861-867. doi: 10.1016/S0140-6736(19)31721-0. Epub 2019 Aug 1.

    PubMed 31378392

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation Paroxysmal, run by Ewha Womans University Mokdong Hospital at 11 sites in South Korea.

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 2 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: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. 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?

Results are not available in the source record.

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?

Occurrence of paroxysmal AF (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05725187, which also lists 5 linked publications.

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 26 Sep 2024.

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