SyncopeNCT02952781
Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
An observational study of Syncope and Presyncope, run by EvergreenHealth at 1 site in United States.
Trial summary
The purpose of this research is to test the clinical value of a new P-wave sensitive recording vector compared to a standard ECG limb lead II vector from similar easy-to-use long-term cardiac rhythm monitoring patch systems, the Carnation TM Ambulatory Monitoring (CAM) System and the Zio-XT iRhythm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syncope, Presyncope, Atrial Fibrillation
- What is being tested?
- EKG Patch monitors (Zio and Carnation)
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to Jan 2017
- 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 followed at the study site's location.
Who may be able to join
- Male or female
- Written informed consent
- Patients with one or more of the following:
- 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.
- Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing
Trial locations and contacts
1 site in 1 country.
United States1 site
EvergreenHealth Heart and Vascular Care
Kirkland, Washington, 98034
About this study
The purpose of this research is to test the clinical value of a new P-wave sensitive recording vector compared to a standard ECG limb lead II vector from similar easy-to-use long-term cardiac rhythm monitoring patch systems, the Carnation TM Ambulatory Monitoring (CAM) System and the Zio-XT iRhythm. The P-wave is a critical aspect of the electrocardiogram. The purpose of this study is to see if the P-wave centric focus of the CAM system improves arrhythmia diagnosis.
Read the detailed description
This study is intended to compare the new Carnation patch monitoring system with the Zio patch, which represents the current standard for continuous recording of the ECG over extended periods. The primary endpoint for this comparison will be diagnostic yield with secondary endpoints being ease of use and comfort.
- Conditions
- Syncope, Presyncope, Atrial Fibrillation, Supraventricular Tachycardia
- Being tested
- EKG Patch monitors (Zio and Carnation)
- Keywords
- ECG Monitoring, Palpitations
- Medical subject headings
- Syncope, Atrial Fibrillation, Tachycardia, Supraventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EKG Patch monitors (Zio and Carnation)Device
Each patient will be provided with both a Zio-XT Patch monitoring system and the CAM system and will be instructed to wear both simultaneously for 7 days.
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.
Measured: 7 days
Secondary outcomes (4)
Skin comfort or discomfort: Was skin irritated?
User will rate skin comfort on pre-determined scale: None, Mild, Moderate, Severe.
Measured: 7 days
Device Comfort
Was device comfortable to wear? User will rate on a predetermined scale: Very Uncomfortable, Mildly Uncomfortable, Comfortable.
Measured: 7 days
Device Stability and Contact
Did the device stay in place in the chest location where it was attached for the time period indicated? Clinician will evaluate visually, and rate on a predetermined scale: Yes, No.
Measured: 7 days
Diagnostic Yield
Diagnostic Yield: proportion of patients for whom an arrhythmogenic source of symptoms is established or eliminated as a diagnosis.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startOct 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- EvergreenHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Vossler, MD, Principal investigator, Evergreenhealth Heart and Vascular Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02952781
- Sponsor's protocol ID
- CZ2016
- Status last verified
- Mar 2017
- First submitted
- 13 Oct 2016
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Bass EB, Curtiss EI, Arena VC, Hanusa BH, Cecchetti A, Karpf M, Kapoor WN. The duration of Holter monitoring in patients with syncope. Is 24 hours enough? Arch Intern Med. 1990 May;150(5):1073-8.
PubMed 2331188Clinical value of vectorcardiography, Holter monitoring and quantitative electrocardiology. Belgian Society of Cardiology. Working Group on Electrocardiology, Exercise Testing and Cardiac Rehabilitation. Acta Cardiol. 2000 Jun;55(3):157-62. doi: 10.2143/AC.55.3.2005733.
PubMed 10902039Bell C, Kapral M. Use of ambulatory electrocardiography for the detection of paroxysmal atrial fibrillation in patients with stroke. Canadian Task Force on Preventive Health Care. Can J Neurol Sci. 2000 Feb;27(1):25-31. doi: 10.1017/s0317167100051933.
PubMed 10676584Brown AP, Dawkins KD, Davies JG. Detection of arrhythmias: use of a patient-activated ambulatory electrocardiogram device with a solid-state memory loop. Br Heart J. 1987 Sep;58(3):251-3. doi: 10.1136/hrt.58.3.251.
PubMed 3663425Calkins H, Byrne M, el-Atassi R, Kalbfleisch S, Langberg JJ, Morady F. The economic burden of unrecognized vasodepressor syncope. Am J Med. 1993 Nov;95(5):473-9. doi: 10.1016/0002-9343(93)90329-n.
PubMed 8238063Clark PI, Glasser SP, Spoto E Jr. Arrhythmias detected by ambulatory monitoring. Lack of correlation with symptoms of dizziness and syncope. Chest. 1980 Jun;77(6):722-5. doi: 10.1378/chest.77.6.722.
PubMed 7398383Cumbee SR, Pryor RE, Linzer M. Cardiac loop ECG recording: a new noninvasive diagnostic test in recurrent syncope. South Med J. 1990 Jan;83(1):39-43. doi: 10.1097/00007611-199001000-00013.
PubMed 2300833
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial
- ClinicalTrials.gov ID
- NCT02952781
- Acronym / sponsor ID
- CZ2016
- Conditions
- Syncope, Presyncope, Atrial Fibrillation, Supraventricular Tachycardia
- Keywords
- ECG Monitoring, Palpitations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- EvergreenHealthUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 2 Nov 2016 (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 purpose of this research is to test the clinical value of a new P-wave sensitive recording vector compared to a standard ECG limb lead II vector from similar easy-to-use long-term cardiac rhythm monitoring patch systems, the Carnation TM Ambulatory Monitoring (CAM) System and the Zio-XT iRhythm. The P-wave is a critical aspect of the electrocardiogram. The purpose of this study is to see if the P-wave centric focus of the CAM system improves arrhythmia diagnosis.
Detailed description
This study is intended to compare the new Carnation patch monitoring system with the Zio patch, which represents the current standard for continuous recording of the ECG over extended periods. The primary endpoint for this comparison will be diagnostic yield with secondary endpoints being ease of use and comfort.
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 followed at the study site's location.
Key inclusion criteria (7 listed)
- Male or female
- Written informed consent
- Patients with one or more of the following:
Key exclusion criteria (3 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.
- Cognitive deficits that would interfere with the subject's ability to give informed consent or perform study testing
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 |
|---|---|---|
| EKG Patch monitors (Zio and Carnation)Each patient will be provided with both a Zio-XT Patch monitoring system and the CAM system and will be instructed to wear both simultaneously for 7 days. | Device | – |
Primary outcome
ECG signal quality
Time frame: 7 days
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.
4 secondary outcomes
Skin comfort or discomfort: Was skin irritated?
Time frame: 7 days
Device Comfort
Time frame: 7 days
Device Stability and Contact
Time frame: 7 days
Diagnostic Yield
Time frame: 7 days
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 7 Mar 2017.
- Results publication: PubMed 2331188Bass EB, Curtiss EI, Arena VC, Hanusa BH, Cecchetti A, Karpf M, Kapoor WN. The duration of Holter monitoring in patients with syncope. Is 24 hours enough? Arch Intern Med. 1990 May;150(5):1073-8.
- Results publication: PubMed 10902039Clinical value of vectorcardiography, Holter monitoring and quantitative electrocardiology. Belgian Society of Cardiology. Working Group on Electrocardiology, Exercise Testing and Cardiac Rehabilitation. Acta Cardiol. 2000 Jun;55(3):157-62. doi: 10.2143/AC.55.3.2005733.
- Results publication: PubMed 10676584Bell C, Kapral M. Use of ambulatory electrocardiography for the detection of paroxysmal atrial fibrillation in patients with stroke. Canadian Task Force on Preventive Health Care. Can J Neurol Sci. 2000 Feb;27(1):25-31. doi: 10.1017/s0317167100051933.
- Results publication: PubMed 3663425Brown AP, Dawkins KD, Davies JG. Detection of arrhythmias: use of a patient-activated ambulatory electrocardiogram device with a solid-state memory loop. Br Heart J. 1987 Sep;58(3):251-3. doi: 10.1136/hrt.58.3.251.
- Results publication: PubMed 8238063Calkins H, Byrne M, el-Atassi R, Kalbfleisch S, Langberg JJ, Morady F. The economic burden of unrecognized vasodepressor syncope. Am J Med. 1993 Nov;95(5):473-9. doi: 10.1016/0002-9343(93)90329-n.
- Results publication: PubMed 7398383Clark PI, Glasser SP, Spoto E Jr. Arrhythmias detected by ambulatory monitoring. Lack of correlation with symptoms of dizziness and syncope. Chest. 1980 Jun;77(6):722-5. doi: 10.1378/chest.77.6.722.
- Results publication: PubMed 2300833Cumbee SR, Pryor RE, Linzer M. Cardiac loop ECG recording: a new noninvasive diagnostic test in recurrent syncope. South Med J. 1990 Jan;83(1):39-43. doi: 10.1097/00007611-199001000-00013.
- Individual participant dataSharing planned: No
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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.
Mark Vossler, MD principal investigator
Evergreenhealth Heart and Vascular Care
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 EvergreenHealth at 1 site in United States.
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 7 inclusion and 3 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 7 Mar 2017. 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 United States. 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?
ECG signal quality (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02952781, which also lists 7 linked publications.
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 7 Mar 2017.