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

Changi General Hospital

Status: Completed

Conditions: Arrythmia; Bradyarrhythmia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06977789

2019/2960

Details and patient eligibility

About

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.

Enrollment: 73 patients

Sex: All

Ages: 60 to 120 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

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

Active Comparator group

Description:

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

Treatment:

Device: Holter

Device: S Patch3-Cardio/S-Patch Ex

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

Active Comparator group

Description:

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

Treatment:

Device: Holter

Device: S Patch3-Cardio/S-Patch Ex