NCT07722039Toborzás még nem indult
Clinical Validation of SMD-RVECG for Predicting Atrial Fibrillation With Rapid Ventricular Response Within 2 Hours
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 23.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 348 (tervezett)
- Első benyújtás
- 2026. júl. 20.
- Kezdés
- 2026. okt. 1.
- Elsődleges befejezés
- 2026. nov. 30.
- Fő szponzor
- HUINNO Co., Ltd
- Betegségek
- Pitvarfibrilláció
- NCT-szám
- NCT07722039
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 348
- 2026. okt. 1. és az elsődleges befejezés (2026. nov. 30.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Data previously used for training or validation of the artificial intelligence model
Más betegség
- Electrocardiogram data with a heart rate below 30 beats per minute or above 300 beats per minute
- Electrocardiogram data from a participant whose baseline heart rate remained at 110 beats per minute or greater irrespective of atrial fibrillation
Egyéb
- 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
- Data collected from a participant who was pregnant or breastfeeding at the time of data collection
- Data considered unsuitable for this clinical study by the principal investigator
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 19 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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