Study Comparing Two Heart Monitoring Devices

Not Applicable

• Conditions: Health Condition 1: I499- Cardiac arrhythmia, unspecified

• Registration Number: CTRI/2024/04/065617
• Lead Sponsor: itto Denko Asia Technical Centre Pte Ltd,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the equivalence of ECG electrical signals of EG Holter PX3.0 with Bittium Faros 360Timepoint: Baseline to 24 Hours

Secondary Outcome Measures

Name	Time	Method
Patient experiences; Effect on skin and Ease of useTimepoint: At 24 Hours; 48 Hours and at 72 Hours