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

NCT06977789 | Completed

• 1 other identifier: 2019/2960
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bradyarrhythmia; Arrythmia

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (2)

• Device sensitivity and specificity

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

• Durability of the device

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

Study Arms (2)

Group A (Holter for 24 hour follow by S Patch3-Cardio/S-Patch Ex for 72 hours)

ACTIVE COMPARATOR

Holter for 24 hour follow by S Patch3-Cardio/S-Patch Ex for 72 hours

Device: S Patch3-Cardio/S-Patch Ex; Device: Holter

Group B (S Patch3-Cardio/S-Patch Ex for 72 hours follow by Holter for 24hour).

ACTIVE COMPARATOR

S Patch3-Cardio/S-Patch Ex for 72 hours follow by Holter for 24hour

Device: S Patch3-Cardio/S-Patch Ex; Device: Holter

Interventions

S Patch3-Cardio/S-Patch Ex DEVICE

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

Group A (Holter for 24 hour follow by S Patch3-Cardio/S-Patch Ex for 72 hours); Group B (S Patch3-Cardio/S-Patch Ex for 72 hours follow by Holter for 24hour).

Holter DEVICE

Holter for 24 hours

Group A (Holter for 24 hour follow by S Patch3-Cardio/S-Patch Ex for 72 hours); Group B (S Patch3-Cardio/S-Patch Ex for 72 hours follow by Holter for 24hour).

Eligibility Criteria

• Age: 60 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Changi General Hospital: lead
• Samsung SDS Asia Pacific Pte Ltd: collaborator

Study Sites (1)

Changi General Hospital

Singapore, Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Bradycardia; Arrhythmias, Cardiac

Interventions

Electrocardiography, Ambulatory

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electrocardiography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Monitoring, Ambulatory; Monitoring, Physiologic

Study Officials

• Yeo Colin

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 18, 2025
• Study Start: July 3, 2020
• Primary Completion: July 31, 2023
• Study Completion: December 25, 2023
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)