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Completed

NCT Number: NCT06977789

Comparison of Holter vs S-Patch for Arrhythmia Detection in Older Falls Patient

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.

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Key information

Conditions

Bradyarrhythmia Arrhythmias, Cardiac Arrythmia Bradycardia Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital

Singapore, 529889

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 60 to 120 year old inclusive
  • Refer for Holter testing as part of clinical care
  • Participants with symptoms suspected to be due to bradyarrhythmia. This could include, but not limited to unwitnessed fall, syncope, near syncope.

Exclusion criteria

  • Participants who are already known to have significant bradyarrhythmia who would benefit from a permanent pacemaker.
  • Patients unable to tolerate Holter monitoring.

Treatment and study plan

S Patch3-Cardio/S-Patch Ex

Device

S Patch3-Cardio/S-Patch Ex for 72 hours

Holter

Device

Holter for 24 hours

Primary outcomes

  1. Participant's Compliance

    Time frame: From date of randomization until the day participant completed both device monitoring, assessed up to 4 days.

    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.

Secondary outcomes

  1. Device sensitivity and specificity

    Time frame: 72 hours for S Patch3-Cardio/S-Patch Ex and 24hours for Holter

    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.

  2. Durability of the device

    Time frame: 72 hours for S Patch3-Cardio/S-Patch Ex and 24hours for Holter

    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.

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Collaborators

  • Samsung SDS Asia Pacific Pte Ltd

Registry information

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 18, 2025
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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