BradyarrhythmiaNCT06977789
Comparison of Holter vs S-Patch for Arrhythmia Detection in Older Falls Patient
A study testing S Patch3-Cardio/S-Patch Ex and Holter in people with Bradyarrhythmia and Arrythmia, run by Changi General Hospital at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 120 years
- Conditions the study is for
- Bradyarrhythmia, Arrythmia
- What is being tested?
- S Patch3-Cardio/S-Patch Ex and Holter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteSingapore
- Study dates
- 3 Jul 2020to 25 Dec 2023
- Phase
- Interventional
- 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 60 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Participants who are already known to have significant bradyarrhythmia who would benefit from a permanent pacemaker.
- Patients unable to tolerate Holter monitoring.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- S Patch3-Cardio/S-Patch Ex, Holter
- Medical subject headings
- Bradycardia, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S Patch3-Cardio/S-Patch ExDevice
S Patch3-Cardio/S-Patch Ex for 72 hours
HolterDevice
Holter for 24 hours
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: S Patch3-Cardio/S-Patch Ex; Device: Holter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of randomization until the day participant completed both device monitoring, assessed up to 4 days.
Secondary outcomes (2)
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.
Measured: 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.
Measured: 72 hours for S Patch3-Cardio/S-Patch Ex and 24hours for Holter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start3 Jul 2020
- Primary completion31 Jul 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradyarrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung SDS Asia Pacific Pte Ltd
- Responsible party
- Principal investigator, Colin Yeo, Changi General Hospital
- Investigators
- Yeo Colin, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977789
- Sponsor's protocol ID
- 2019/2960
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 18 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Holter vs S-Patch for Arrhythmia Detection in Older Falls Patient
- ClinicalTrials.gov ID
- NCT06977789
- Acronym / sponsor ID
- 2019/2960
- Conditions
- Bradyarrhythmia, Arrythmia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- Samsung SDS Asia Pacific Pte Ltd
- Study start
- 3 Jul 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Holter for 24 hour follow by S Patch3-Cardio/S-Patch Ex for 72 hours) | Active comparator | Device: S Patch3-Cardio/S-Patch Ex, Device: HolterHolter 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). | Active comparator | Device: S Patch3-Cardio/S-Patch Ex, Device: HolterS Patch3-Cardio/S-Patch Ex for 72 hours follow by Holter for 24hour |
Who may qualify
- Ages
- 60 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Participants who are already known to have significant bradyarrhythmia who would benefit from a permanent pacemaker.
- Patients unable to tolerate Holter monitoring.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S Patch3-Cardio/S-Patch ExS Patch3-Cardio/S-Patch Ex for 72 hours | Device | 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). |
| HolterHolter for 24 hours | Device | 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). |
Primary outcome
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.
2 secondary outcomes
Device sensitivity and specificity
Time frame: 72 hours for S Patch3-Cardio/S-Patch Ex and 24hours for Holter
Durability of the device
Time frame: 72 hours for S Patch3-Cardio/S-Patch Ex and 24hours for Holter
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeo Colin principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing S Patch3-Cardio/S-Patch Ex and Holter in people with Bradyarrhythmia and Arrythmia, run by Changi General Hospital at 1 site in Singapore.
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 3 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: finished, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Participant's Compliance (time frame: From date of randomization until the day participant completed both device monitoring, assessed up to 4 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2025.