ArrhythmiaNCT01913561
The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection
A study testing Master Caution Garment and ECG gel electrodes in people with Arrhythmia, run by HealthWatch Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Master Caution Garment and ECG gel electrodes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to 31 Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age>18 years.
- Suspected for arrhythmia or have evidence of arrhythmia disorder.
- Needs continuous, in-hospital ECG monitoring.
- Ability to give informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection Compared To Standard Gel-Electrode-Based ECG
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.
Read more
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.
Read the detailed description
Part A - ECG in Rest
- In the beginning of the study, the following parameters will be measured and documented in the CRF: blood pressure, body temperature, respiratory rate and oxygen saturation in the blood.
- The patient will be dressed with the Master Caution Garment and connected to a 12 lead ECG device. The procedure takes 5 minutes including data printing.
- A twelve lead ECG with gel electrodes will be done and data printed. The procedure takes 5 minutes. The patient will stay connected to the monitor for the following hour.
- After an hour the data from the gel electrodes will be printed again.
- The patient will be dressed again with the Master Caution Garment and connected to a 12 lead ECG device. The procedure takes 5 minutes including data printing.
- The following parameters will be compared between the gel ECG and the Garment ECG:
- Heart Rate (HR)
- P wave width and amplitude
- QRS complex width and amplitude
- T wave width and amplitude
- RR interval
- PR interval
- QT interval
Part B - ECG in motion
- In the beginning of the study, the following parameters will be measured : blood pressure, body temperature, respiratory rate and oxygen saturation in the blood.
- Four (4) gel electrodes will be placed on the patient on the following places - Left Arm (LA), Right Arm (RA), Left Leg (LL) and Right Leg (RL).
- The patient will be dressed with the Master Caution Garment (MCG)on the 4 gel electrodes that were already placed.
- The same 4 electrodes in the garment LA, RA, LL and RL will be connected to a standard of care ECG device.
- The 4 gel electrodes will be connected to a standard of care ECG device.
- The ECG devices will be recording the ECG signal from the two sets of electrodes for 24 hours. Every hour in the first 6 hours the data will be printed from both devices. In every event detected the data will be printed from both devices. the data will be evaluated for quality comparison between the gel and the textile electrodes using the hospital ECG device.
- In first 6 hours for every hour and for each event detected by either the gel electrodes or the MCG textile electrodes the following parameters shell be evaluated at the end of the study from the hospital ECG printouts for the Master Caution Garment and for the gel electrodes:
- Heart Rate (HR)
- P wave width and amplitude
- QRS complex width and amplitude
- T wave width and amplitude
- RR interval
- PR interval
- QT interval After first 6 hours for each event detected by either the gel electrodes or the MCG textile electrodes the above mentioned parameters shell be evaluated at the end of the study from the hospital ECG printouts for the Master Caution Garment and for the gel electrodes.
The goal of the current study is to evaluate the safety of the MCG and compare ECG signals from the Master Caution Garment with the ECG signals from gel electrodes.
This is a prospective, comparative study.
For each time interval and each event detected by the ECG devices, the analysis will determine its category as follows:
- Blinded cardiologist's assessment whether at that time interval the patient suffered from a disorder. This assessment will be based on hospital's recorded data with the gel electrodes.
- The Master Caution Garment result for that time interval will be categorized as follows:
- True Positive (TP) = MCG Alert was right (based on GS)
- False Positive (FP) = MCG Alert was wrong
- True Negative (TN) = No MCG Alert when indeed alert was not necessary
- False Negative (FN) = No MCG Alert but there was a disorder case
- Conditions
- Arrhythmia
- Being tested
- Master Caution Garment, ECG gel electrodes
- Keywords
- Electrocardiogram, gel electrodes, textile electrodes
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Master Caution GarmentDevice
Also called MCG
Master Caution Garment is embedded with 10/13 textile dry electrodes that enable 12/15-lead ECG.
The electrodes are dry, textile ECG electrodes.
ECG gel electrodesDevice
Standard gel electrodes that are been in use in hospital for ECG monitoring.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Master Caution Garment; Device: ECG gel electrodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
From the ECG record collect the Heart Rate HR.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.).
Measured: 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.).
Measured: 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.).
Measured: 0,1,2,3,4,5,6 hours and in each arrythemia event detected durring 24 hours from the start of the ECG recording.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthWatch Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Zukerman, Dr., Principal investigator, Rambam medical center Haifa, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01913561
- Sponsor's protocol ID
- HWG001
- Status last verified
- Aug 2018
- First submitted
- 24 Jul 2013
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Master Caution Garment for Continuous Monitoring for Arrhythmia Detection Compared To Standard Gel-Electrode-Based ECG
- ClinicalTrials.gov ID
- NCT01913561
- Acronym / sponsor ID
- HWG001
- Conditions
- Arrhythmia
- Keywords
- Electrocardiogram, gel electrodes, textile electrodes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- HealthWatch Ltd.Industry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jun 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 1 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Part A - ECG in Rest
- In the beginning of the study, the following parameters will be measured and documented in the CRF: blood pressure, body temperature, respiratory rate and oxygen saturation in the blood.
- The patient will be dressed with the Master Caution Garment and connected to a 12 lead ECG device. The procedure takes 5 minutes including data printing.
- A twelve lead ECG with gel electrodes will be done and data printed. The procedure takes 5 minutes. The patient will stay connected to the monitor for the following hour.
- After an hour the data from the gel electrodes will be printed again.
- The patient will be dressed again with the Master Caution Garment and connected to a 12 lead ECG device. The procedure takes 5 minutes including data printing.
- The following parameters will be compared between the gel ECG and the Garment ECG:
- Heart Rate (HR)
- P wave width and amplitude
- QRS complex width and amplitude
- T wave width and amplitude
- RR interval
- PR interval
- QT interval
Part B - ECG in motion
- In the beginning of the study, the following parameters will be measured : blood pressure, body temperature, respiratory rate and oxygen saturation in the blood.
- Four (4) gel electrodes will be placed on the patient on the following places - Left Arm (LA), Right Arm (RA), Left Leg (LL) and Right Leg (RL).
- The patient will be dressed with the Master Caution Garment (MCG)on the 4 gel electrodes that were already placed.
- The same 4 electrodes in the garment LA, RA, LL and RL will be connected to a standard of care ECG device.
- The 4 gel electrodes will be connected to a standard of care ECG device.
- The ECG devices will be recording the ECG signal from the two sets of electrodes for 24 hours. Every hour in the first 6 hours the data will be printed from both devices. In every event detected the data will be printed from both devices. the data will be evaluated for quality comparison between the gel and the textile electrodes using the hospital ECG device.
- In first 6 hours for every hour and for each event detected by either the gel electrodes or the MCG textile electrodes the following parameters shell be evaluated at the end of the study from the hospital ECG printouts for the Master Caution Garment and for the gel electrodes:
- Heart Rate (HR)
- P wave width and amplitude
- QRS complex width and amplitude
- T wave width and amplitude
- RR interval
- PR interval
- QT interval After first 6 hours for each event detected by either the gel electrodes or the MCG textile electrodes the above mentioned parameters shell be evaluated at the end of the study from the hospital ECG printouts for the Master Caution Garment and for the gel electrodes.
The goal of the current study is to evaluate the safety of the MCG and compare ECG signals from the Master Caution Garment with the ECG signals from gel electrodes.
This is a prospective, comparative study.
For each time interval and each event detected by the ECG devices, the analysis will determine its category as follows:
- Blinded cardiologist's assessment whether at that time interval the patient suffered from a disorder. This assessment will be based on hospital's recorded data with the gel electrodes.
- The Master Caution Garment result for that time interval will be categorized as follows:
- True Positive (TP) = MCG Alert was right (based on GS)
- False Positive (FP) = MCG Alert was wrong
- True Negative (TN) = No MCG Alert when indeed alert was not necessary
- False Negative (FN) = No MCG Alert but there was a disorder case
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Master Caution Garment | Experimental | Device: Master Caution Garment, Device: ECG gel electrodeseach 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age>18 years.
- Suspected for arrhythmia or have evidence of arrhythmia disorder.
- Needs continuous, in-hospital ECG monitoring.
- Ability to give informed consent.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Master Caution GarmentAlso: MCGMaster Caution Garment is embedded with 10/13 textile dry electrodes that enable 12/15-lead ECG. The electrodes are dry, textile ECG electrodes. | Device | Master Caution Garment |
| ECG gel electrodesStandard gel electrodes that are been in use in hospital for ECG monitoring. | Device | Master Caution Garment |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Zukerman, Dr. principal investigator
Rambam medical center Haifa, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Master Caution Garment and ECG gel electrodes in people with Arrhythmia, run by HealthWatch Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2018.