SyncopeNCT02126631
Sternal ECG Patch Comparison Trial
An observational study of Syncope and Presyncope, run by Bardy Diagnostics, Inc. at 1 site in New Zealand.
Trial summary
This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a patch monitoring system, with the Holter monitoring system. Holters represent the current standard for continuous recording of the ECG over extended periods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope, Presyncope, Palpitations
- How many people
- 50 participants
- Where
- 1 siteNew Zealand
- Study dates
- Jul 2014to Jul 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac patients at Auckland City Hospital, Auckland, New Zealand
Who may be able to join
- Syncope of uncertain etiology or
- Pre-syncope of uncertain etiology or
- Palpitations of uncertain etiology or
- Management of known AF/SVT patients
Who cannot join
- Any dermatitis or infected skin over the sternum (Carnation patch) or left upper anterior thorax (Zio patch).
- A sternal or thoracic incision that extends under the patch within 3 months from the date of enrollment
Trial locations and contacts
1 site in 1 country.
New Zealand1 site
Auckland City Hospital
Auckland, 1142
Warren Smith, MBChB, +64 (021) 774 140, WarrenS@adhb.govt.nz
Warren Smith, MBChB
About this study
Official title: Comparison of a Sternal ECG Patch With a Standard Recording System for Holter Monitoring
This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a patch monitoring system, with the Holter monitoring system. Holters represent the current standard for continuous recording of the ECG over extended periods.
Read the detailed description
The purpose of this research is to simplify the system of recording ECGs. Carnation Ambulatory Monitoring (CAM) System is a small patch system that can be worn during most activities include showering. Each patient will be his or her own control, and will wear the CAM and Holter systems simultaneously for 24 hours. Both systems will then be sent out for analysis.
- Medical subject headings
- Syncope, Atrial Fibrillation, Tachycardia, Supraventricular
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG signal quality
ECG signal quality = scoring the ability of each system to record electrical activity from the atrium (P-waves). The Physician Event Committee will independently score the P-waves from all recordings, using the following scale: Excellent, Good, Fair, Poor, Non-existent. Diagnostic yield will also be assessed.
Measured: 24 hours of patient use, plus shipping and analysis time ~ 2 weeks
Secondary outcomes (1)
Device comfort
Secondary outcome measures will include Human Factors performance of the 2 systems, which will be scored and compared in the following areas and duration of patch adherence: skin irritation, comfort, contact and stability.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2014 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bardy Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jon Hunt, PhD, Study director, Bardy Diagnostics, Inc. (sponsor)Warren Smith, MBChB, Principal investigator, Auckland City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02126631
- Sponsor's protocol ID
- 6147
- Status last verified
- Jun 2014
- First submitted
- 28 Apr 2014
- Last updated
- 26 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of a Sternal ECG Patch With a Standard Recording System for Holter Monitoring
- ClinicalTrials.gov ID
- NCT02126631
- Acronym / sponsor ID
- 6147
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Bardy Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Jul 2014 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 30 Apr 2014 (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.
This study is intended to compare the new Carnation Ambulatory Monitoring (CAM) System, a patch monitoring system, with the Holter monitoring system. Holters represent the current standard for continuous recording of the ECG over extended periods.
Detailed description
The purpose of this research is to simplify the system of recording ECGs. Carnation Ambulatory Monitoring (CAM) System is a small patch system that can be worn during most activities include showering. Each patient will be his or her own control, and will wear the CAM and Holter systems simultaneously for 24 hours. Both systems will then be sent out for analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac patients at Auckland City Hospital, Auckland, New Zealand
Key inclusion criteria (4 listed)
- Syncope of uncertain etiology or
- Pre-syncope of uncertain etiology or
- Palpitations of uncertain etiology or
- Management of known AF/SVT patients
Key exclusion criteria (2 listed)
- Any dermatitis or infected skin over the sternum (Carnation patch) or left upper anterior thorax (Zio patch).
- A sternal or thoracic incision that extends under the patch within 3 months from the date of enrollment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
ECG signal quality
Time frame: 24 hours of patient use, plus shipping and analysis time ~ 2 weeks
ECG signal quality = scoring the ability of each system to record electrical activity from the atrium (P-waves). The Physician Event Committee will independently score the P-waves from all recordings, using the following scale: Excellent, Good, Fair, Poor, Non-existent. Diagnostic yield will also be assessed.
1 secondary outcome
Device comfort
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2014.
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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.
Jon Hunt, PhD study director
Bardy Diagnostics, Inc. (sponsor)
Warren Smith, MBChB principal investigator
Auckland City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope and Presyncope, run by Bardy Diagnostics, Inc. at 1 site in New Zealand.
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 2 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: status not confirmed, as of the sponsor's last update on 26 Jun 2014. 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 New Zealand. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG signal quality (time frame: 24 hours of patient use, plus shipping and analysis time ~ 2 weeks). 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 26 Jun 2014.