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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by HealthWatch Ltd.
Sponsor:
Information provided by (Responsible Party):
HealthWatch Ltd.
ClinicalTrials.gov Identifier:
NCT01913561
First received: July 24, 2013
Last updated: November 3, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Arrhythmia
Device: Master Caution Garment
Device: ECG gel electrodes

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection Compared To Standard Gel-Electrode-Based ECG

Further study details as provided by HealthWatch Ltd.:

Primary Outcome Measures:
  • From the ECG record collect the Heart Rate HR. [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ] [ Designated as safety issue: No ]
  • From the ECG record collect the P Wave width (sec.) and the amplitude (mV). [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ] [ Designated as safety issue: No ]
  • From the ECG record collect the QRS Complex width (sec.) and the amplitude (mV). [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ] [ Designated as safety issue: No ]
  • From the ECG record collect the T Wave width (sec.) and the amplitude (mV). [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ] [ Designated as safety issue: No ]
  • From the ECG record collect the RR Interval width (sec.). [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ] [ Designated as safety issue: No ]
  • From the ECG record collect the PR Interval width (sec.). [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ] [ Designated as safety issue: No ]
  • From the ECG record collect the QT Interval width (sec.). [ Time Frame: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording. ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Master Caution Garment

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

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

The electrodes are dry, textile ECG electrodes.

Other Name: MCG
Device: ECG gel electrodes
Standard gel electrodes that are been in use in hospital for ECG monitoring.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01913561

Contacts
Contact: Hila Dagan, Dr. 972-54-7936392 hila.d@personal-healthwatch.com
Contact: Uri Amir, Mr. 972-52-4235736 uri.a@personal-healthwatch.com

Locations
Israel
Rambam medical center Recruiting
Haifa, Israel, 9602
Contact: Robert Z, Zukerman    972-4-85426756    r_zukerman@rambam.health.org.il   
Contact: Dina Azulay, Ms    972-4-8542181    d_azulay@rambam.health.gov.il   
Principal Investigator: Robert Zukerman, Dr.         
Sponsors and Collaborators
HealthWatch Ltd.
Investigators
Principal Investigator: Robert Zukerman, Dr. Rambam medical center Haifa, Israel
  More Information

No publications provided

Responsible Party: HealthWatch Ltd.
ClinicalTrials.gov Identifier: NCT01913561     History of Changes
Other Study ID Numbers: HWG001
Study First Received: July 24, 2013
Last Updated: November 3, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by HealthWatch Ltd.:
Electrocardiogram
gel electrodes
textile electrodes

ClinicalTrials.gov processed this record on September 22, 2014