A Comparative Study of an Innovative 3-lead Wireless Water Resistant Holter System and a Conventional Holter System

NCT04723355 | Completed Results

• 1 other identifier: 40422220.1.0000.5462
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

Brief Summary

Holter monitoring is one of the most widely used diagnostic methods to detect cardiac arrhythmias. Newer Holter monitors may provide some advantages over the more traditional ones. This study will compare the findings of a Holter exam using an innovative 3-lead wireless water resistant device with a conventional device.

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (1)

• Detection of Cardiac Arrhythmias

  Number of patients with cardiac arrhythmias detected in both Holter monitors, including a) atrial fibrillation or atrial flutter; b) supraventricular tachycardia (any tachycardia with ≥ 3 beats arising outside the sinus node and above the His-Purkinje bifurcation, including atrial tachycardia, atrioventricular nodal reentry tachycardia, junctional tachycardia and accessory pathway reentry tachycardia, except atrial fibrillation and atrial flutter); c) ventricular tachycardia (any tachycardia with ≥ 3 beats arising from the ventricles, except polymorphic ventricular tachycardia or ventricular fibrillation); d) polymorphic ventricular tachycardia or ventricular fibrillation; e) atrioventricular (AV) block (high-degree AV block, in which there is an interruption in the transmission of a heart beat from the atria to the ventricles, including those classified as 2nd degree AV block Mobitz type I and II, AV block 2:1 or complete AV block); or f) heart beat pauses (≥ 2,5 seconds)

  24 hours

Secondary Outcomes (16)

• Detection of Atrial Fibrillation or Atrial Flutter

  24 hours

• Detection of Supraventricular Tachycardia

  24 hours

• Detection of Ventricular Tachycardia

  24 hours

• Detection of Polymorphic Ventricular Tachycardia or Ventricular Fibrillation

  24 hours

• Detection of Atrioventricular Block

  24 hours

Study Arms (1)

Holter device

EXPERIMENTAL

In this single arm of the study, the participant will use 2 Holter systems simultaneously for 24 hours, an innovative 3-lead wireless water resistant device and a conventional device.

Device: An innovative 3-lead wireless water resistant Holter device; Device: A conventional device

Interventions

An innovative 3-lead wireless water resistant Holter device DEVICE

The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.

Holter device

A conventional device DEVICE

The participant will use the innovative 3-lead wireless water resistant Holter device simultaneously with the conventional Holter device for 24 hours.

Holter device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any individual who has an indication of 24 hours Holter monitoring and is referred to the arrhythmia clinic of the Instituto Dante Pazzanese de Cardiologia

You may not qualify if:

• Refusal to provide written informed consent

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Instituto Dante Pazzanese de Cardiologia: collaborator
• Quoretech: collaborator

Study Sites (1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Trialist
• Organization: Hospital Israelita Albert Einstein

karla.santo@einstein.br

551121515915

Study Officials

• Karla Santo, PhD

  Hospital Israelita Albert Einstein

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 25, 2021
• Study Start: January 26, 2021
• Primary Completion: November 16, 2021
• Study Completion: November 16, 2021
• Last Updated: October 24, 2024
• Results First Posted: October 24, 2024

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)