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Study Comparing Two Heart Monitoring Devices

A prospective, open label, pilot study to compare ECG electrical signals of EG Holter PX3.0 with Bittium Faros 360 (3 channel lead-set with 5 electrodes) ECG Holter to evaluate equivalence via analysis using FDA approved Bittium software without intended use in arrythmia(s) treatment - NIL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065617
Enrollment
55
Registered
2024-04-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I499- Cardiac arrhythmia, unspecified

Interventions

Intervention1: EG Holter PX3.0: Patch type electrocardiograph Control Intervention1: Bittium Faros 360: 3 channel lead-set with 5 electrodes

Sponsors

Nitto Denko Asia Technical Centre Pte Ltd,
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Subjects judged by PI with cardiac arrhythmia(s); Inclusion Criteria based on clinical symptoms 1.Unexplained syncope 2.Recurrent palpitation 3.Mitral valve prolapse with palpitations 4.IHD with severe LV dysfunction 5.Suspected Prinz metal angina 6.COPD patients with palpitations Inclusion criteria on documented arrhythmias 1.Atrial fibrillation (paroxysmal or chronic) 2.Ventricular Tachycardia (sustained or non sustained) 3.Bundle branch block. 4.Supra ventricular Tachycardias including WPW syndrome. 5.Frequent ventricular premature contractions or atrial premature contractions 6.Sinus Bradycardia 7.Sick sinus syndrome 8.First degree or second degree or suspected intermittent third degree atrio ventricular blocks. 9.After initial catheter ablation treatment for atrial fibrillation. 10.Persons with a history of cerebral infarction or transient ischemic attack (TIA) 11.Willing to give written informed consent and adhere to all the requirements of this protocol.

Exclusion criteria

Exclusion criteria: Subjects with any of the following will be excluded from the participation/enrollment in the clinical trial: 1.As per under use medical device instruction of use. 2.Pregnant and lactating female. 3.Subjects who are chronic smokers and alcoholics 4.Subject having known derma allergy. 5.Any other as adjudicated by PI

Design outcomes

Primary

MeasureTime frame
Assess the equivalence of ECG electrical signals of EG Holter PX3.0 with Bittium Faros 360Timepoint: Baseline to 24 Hours—

Secondary

MeasureTime frame
Patient experiences; Effect on skin and Ease of useTimepoint: At 24 Hours; 48 Hours and at 72 Hours—

Countries

India

Contacts

Public ContactDivya Chandradhara
divya@bioagiletherapeutics.com9538961761

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026