The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection

NCT01913561 | Completed

• 1 other identifier: HWG001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The Master Caution Garment is embedded with 10/13 textile dry electrodes that enable 12/15-lead ECG. The electrodes are dry, textile ECG electrodes. The garment is designed to position the electrodes in the appropriate anatomical locations, without any special guidance. The dry electrodes are made from unique yarns with silver embedded into the garment using a proprietary technique developed by HealthWatch (HW)that obviates the need for skin preparation or the application of fluids. The garment can be connected to any standard ECG device available in the hospitals. The purpose of this study is to evaluate the safety and effectiveness of the Master Caution Garment for continuous monitoring of ECG signal compared to standard gel electrodes. The following endpoints will be evaluated in subjects participating in the study: Primary: Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes using standard ECG devices. Secondary: Compare the quality of the ECG signal of HW textile electrodes compared to gel electrodes when event is detected by the ECG devices.

Conditions

Arrhythmia

Keywords

Electrocardiogram; gel electrodes; textile electrodes

Outcome Measures

Primary Outcomes (7)

• From the ECG record collect the Heart Rate HR.

  0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.

• From the ECG record collect the P Wave width (sec.) and the amplitude (mV).

  0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.

• From the ECG record collect the QRS Complex width (sec.) and the amplitude (mV).

  0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.

• From the ECG record collect the T Wave width (sec.) and the amplitude (mV).

  0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.

• From the ECG record collect the RR Interval width (sec.).

  0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.

• From the ECG record collect the PR Interval width (sec.).

  0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.

• From the ECG record collect the QT Interval width (sec.).

  0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.

Study Arms (1)

Master Caution Garment

EXPERIMENTAL

each patient will be connected simultaneously with two devices: * ECG gel electrodes * Master Caution Garment textile electrodes The two devices will be connected to hospital ECG telemetry.

Device: Master Caution Garment; Device: ECG gel electrodes

Interventions

Master Caution Garment DEVICE

Master Caution Garment is embedded with 10/13 textile dry electrodes that enable 12/15-lead ECG. The electrodes are dry, textile ECG electrodes.

Also known as: MCG

Master Caution Garment

ECG gel electrodes DEVICE

Standard gel electrodes that are been in use in hospital for ECG monitoring.

Master Caution Garment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years.
• Suspected for arrhythmia or have evidence of arrhythmia disorder.
• Needs continuous, in-hospital ECG monitoring.
• Ability to give informed consent.

You may not qualify if:

• Patients with known allergy to silver.
• Patients with recent trauma to chest wall.
• Pregnant or lactating woman.
• Patients with chest deformity precluding placement of the garment.
• Patients participating in another ongoing trial.

Sponsors & Collaborators

• HealthWatch Ltd.: lead

Study Sites (1)

Rambam medical center

Haifa, 9602, Israel

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

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

Study Officials

• Robert Zukerman, Dr.

  Rambam medical center Haifa, Israel

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: August 1, 2013
• Study Start: September 1, 2013
• Primary Completion: June 1, 2017
• Study Completion: August 31, 2017
• Last Updated: August 8, 2018

Record last verified: 2018-08

Locations

IL (1)