An interventional study of S Patch3-Cardio/S-Patch Ex and Holter in Bradyarrhythmia and Arrythmia, sponsored by Changi General Hospital. Completed at 1 site in Singapore. Open to participants aged 60 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-05-18.
Sponsored by Changi General Hospital · Not applicable, Interventional, and Diagnostic
The aim of this study is to compare Holter versus S patch in a group of elderly patients who are referred to the Geriatrics service in Changi General Hospital for falls from Accident and Emergency department, clinic and wards.
The investigator hope to assess the feasibility, adherence and patient acceptability as an alternative to Holter monitoring. The investigator also hope to learn if S-Patch EX monitoring system can be as effective or equivalent to Holter in the monitoring of arrhythmias and the possibility of deploying it for longer term monitoring of arrhythmias.
Participants who consented to be in this study will be offered S patch and Holter consecutively. Holter will be worn for 24 hours and S patch will be worn for 72 hours. The order which Holter or S patch will be worn first will be determined via randomisation.
885 studies on the registry are indexed under Arrhythmias, Cardiac; 235 are open to participants now.
This study's enrollment of 73 is below the median of 99 across 429 interventional studies indexed under Arrhythmias, Cardiac.
Browse Arrhythmias, Cardiac studies →Changi General Hospital is the lead sponsor of 98 studies on the registry; 18 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Holter for 24 hour follow by S Patch3-Cardio/S-Patch Ex for 72 hours
Device: S Patch3-Cardio/S-Patch Ex · Device: Holter
S Patch3-Cardio/S-Patch Ex for 72 hours follow by Holter for 24hour
Device: S Patch3-Cardio/S-Patch Ex · Device: Holter
S Patch3-Cardio/S-Patch Ex for 72 hours
Holter for 24 hours
Participant's Compliance
An events diary and questionnaire to evaluate their preference between Holter and the S-Patch recorder. The hours of recording from both devices will also be captured in both devices report.
Time frame: From date of randomization until the day participant completed both device monitoring, assessed up to 4 days.
Device sensitivity and specificity
Assess sensitivity and specificity of S Patch3-Cardio/S-Patch Ex compared to Holter to diagnose the bradyarrhythmia/arrhythmia. The sensitivity and specificity will be analyzed from the device report. Outcome comparison between the two treatment arms using McNemars test.
Time frame: 72 hours for S Patch3-Cardio/S-Patch Ex and 24hours for Holter
Durability of the device
Durability of the device in longer term monitoring and in real world situation. The hours of monitoring from S Patch3-Cardio/S-Patch Ex is compare with hours of monitoring from Holter to see if 72 hours of monitoring will have a better outcome compare to only 24hrs of recording. The duration of recording are taken from the device monitoring reports.
Time frame: 72 hours for S Patch3-Cardio/S-Patch Ex and 24hours for Holter
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Changi General Hospital