Cardiac ArrhythmiaNCT04241692
Comparative Study of the Sternal Patch System With a Conventional Holter Recorder
A study testing CarnationTM Ambulatory Monitoring Sternal ECG Patch System and Conventional 24-Hour 7 Lead Holter Monitor Recorder in people with Cardiac Arrhythmia and Syncope, run by Children's National Research Institute at 1 site in United States.
Trial summary
This study will be a comparison of two externally worn recording systems for documentation of cardiac arrhythmias in symptomatic patients or patients at risk for arrhythmia. Non-invasive documentation of cardiac arrhythmias can be done using the standard electrocardiogram (ECG). Read more about this study
- Who is it for?
- Ages Up to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Arrhythmia, Syncope
- What is being tested?
- CarnationTM Ambulatory Monitoring Sternal ECG Patch System and Conventional 24-Hour 7 Lead Holter Monitor Recorder
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2020to 1 Mar 2023
- 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 Up to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Any infant, child, adolescent, or young adult with one or more of the following:
- Syncope
- Pre-syncope
- Palpitations
- Management of a known or suspected cardiac arrhythmia
Who cannot join
- Any inflamed or friable skin over the anterior thorax and upper abdomen or a sternal incision within 3 months from the date of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's National Hospital
Washington D.C., District of Columbia, 20010
About this study
Official title: Comparative Study of the CarnationTM Ambulatory Monitoring Sternal ECG Patch System With a Conventional 24-Hour 7 Lead Holter Monitor Recorder
This study will be a comparison of two externally worn recording systems for documentation of cardiac arrhythmias in symptomatic patients or patients at risk for arrhythmia. Non-invasive documentation of cardiac arrhythmias can be done using the standard electrocardiogram (ECG). This has limitations given it is performed for only a 10 sec period. Alternative methods for making longer term recording have been developed. The standard device is the 24 hour 7-lead Holter monitor. Newer technology has simplified the hardware needed to make these longer term recordings, and incorporate a self-contained recording system in a patch that is applied over the patient's chest. Little is known comparing the sensitivity, specificity and recording noise / signal artifact between the older technology (standard 24-Hour Holter monitor) and the Patch electrode.
Read the detailed description
Objective: Comparison of two externally worn recording systems for documentation of cardiac arrhythmias in symptomatic patients or patients at risk for arrhythmia. Non-invasive documentation of cardiac arrhythmias can be done by attempting to take a snapshot view of a patient's cardiac rhythm using the standard electrocardiogram (ECG). This has limitations given it is performed for only a 10 sec period, and requires the patient to be symptomatic at the time of the recording. Therefore, the sensitivity of this technique is very low. Alternative methods for making longer term recording have been developed and used for decades. The standard device is the 24 hour 7-lead Holter monitor. These devises are large, restrict patient mobility and require cables to be connected between the applied skin ECG electrodes placed on the patient's chest and the recording device. Newer technology has simplified the hardware needed to make these longer term recordings, and incorporate a self-contained recording system in a patch that is applied over the patient's chest. These units allow for unlimited mobility, are significantly smaller, easier to wear and have eliminated the requirement for cables to connect the electrodes with the recording device. However, little is known comparing the sensitivity, specificity and recording noise / signal artifact between the older technology (standard 24-Hour Holter monitor) and the Patch electrode.
Specific Aims:
Aim 1: Comparison of Cardiac Arrhythmia Documentation between Standard 24-Hour Holter Monitor vs. Patch Monitor To evaluate the diagnostic yield for cardiac arrhythmias between the two recording systems.
The presence and frequency (qualitative and quantitative) of cardiac arrhythmias documented by each recording system with be compared. To allow for this type of comparison, each enrolled research subject with wear both systems simultaneously.
Aim 2: Comparison of Recording Quality between Standard 24-Hour Holter Monitor vs. Patch Monitor To evaluate percentage of time ECG signal quality is poor and uninterpretable.
Aim 3: Comparison of Comfortability Between Standard 24-HourHolter Monitor vs. Patch Monitor Recording Quality To evaluate level of patient's discomfort during the application of each recording system. Since both systems will be applied at the same time it may be hard for the research subject to rank the comfortability of the two systems. We will focus in this aim at more objective measures such as skin irritation under the recording electrodes, and frequency of time during which the skin electrodes come off the patient and require re-application.
Hypotheses:
Aim 1: Comparison of Cardiac Arrhythmia Documentation between Standard 24-Hour Holter Monitor vs. Patch Monitor We hypothesize that there will be no qualitative or quantitative difference in arrhythmia frequency between the two recording techniques, i.e. that both devices will detect all spontaneous arrhythmias with similar quantitative counts of ectopic beats (+/- 5%).
Aim 2: Comparison of Recording Quality between Standard 24-Hour Holter Monitor vs. Patch Monitor We hypothesize that recording quality will be better with the Patch Monitor since there are not 7 separately applied skin electrodes and cables connecting the electrodes with the recorder, resulting in a lower percent of poor ECG signal quality.
Aim 3: Comparison of Comfortability Between Standard 24-hour Holter Monitor vs. Patch Monitor Recording Quality We hypothesize that the degree of skin irritation and level of discomfort in the region of application will be less with the Patch Monitor. We hypothesize that the ECG leads will fall off from its site of application will be less with the Patch Monitor.
- Conditions
- Cardiac Arrhythmia, Syncope
- Being tested
- CarnationTM Ambulatory Monitoring Sternal ECG Patch System, Conventional 24-Hour 7 Lead Holter Monitor Recorder
- Medical subject headings
- Arrhythmias, Cardiac, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarnationTM Ambulatory Monitoring Sternal ECG Patch SystemDevice
A newly developed cardiac rhythm monitoring system
Conventional 24-Hour 7 Lead Holter Monitor RecorderDevice
Traditional recordings made using a standard 24-hour Holter monitor.
| Study group | Role | What they receive |
|---|---|---|
| Application of Carnation Ambulatory Patch Monitoring System | Experimental | The patient will wear a Standard Holter Monitor and the CAM Patch system simultaneously for 24 hours. Receives: Device: CarnationTM Ambulatory Monitoring Sternal ECG Patch System |
| Application Conventional 24-Hour Holter Monitor Recorder | Experimental | The patient will wear a Standard Holter Monitor and the CAM Patch system simultaneously for 24 hours. Receives: Device: Conventional 24-Hour 7 Lead Holter Monitor Recorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Cardiac Arrhythmia Detection Between Recording Systems
The presence (yes/no) and frequency of cardiac arrhythmias will be quantitated on each recording system for comparison
Measured: 24 Hours
Difference in Signal Quality Between Recording Systems
We will quantitatively evaluate percentage of time signal quality is poor and uninterpretable with each recording system.
Measured: 24 Hours
Secondary outcomes (1)
Difference in Skin Discomfort Between Recording Systems
User will rate skin discomfort on a pre-determined scale: none, mild, moderate, severe at each site of application
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 posted27 Jan 2020
- Study start19 Nov 2020
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Mar 2023 (estimated)
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 Cardiac 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- To allow for this type of comparison, each enrolled research subject will wear both systems simultaneously
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeffrey Moak, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04241692
- Sponsor's protocol ID
- Pro00013642
- Status last verified
- Jul 2022
- First submitted
- 22 Jan 2020
- Last updated
- 28 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bigger JT Jr, Reiffel JA, Coromilas J. Ambulatory electrocardiography. In: Platia E, ed. Non-Pharmacologic Management of Cardiac Arrhythmias. Philadelphia: JB Lippincott, 1986:36-61.
Clark 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 7398383Gibson TC, Heitzman MR. Diagnostic efficacy of 24-hour electrocardiographic monitoring for syncope. Am J Cardiol. 1984 Apr 1;53(8):1013-7. doi: 10.1016/0002-9149(84)90628-3.
PubMed 6702676Heilbron EL. Advances in modern electrocardiographic equipment for long-term ambulatory monitoring. Card Electrophysiol Rev. 2002 Sep;6(3):185-9. doi: 10.1023/a:1016322218490.
PubMed 12114836Jonas S, Klein I, Dimant J. Importance of Holter monitoring in patients with periodic cerebral symptoms. Ann Neurol. 1977 May;1(5):470-4. doi: 10.1002/ana.410010511.
PubMed 363045Kapoor WN, Cha R, Peterson JR, Wieand HS, Karpf M. Prolonged electrocardiographic monitoring in patients with syncope. Importance of frequent or repetitive ventricular ectopy. Am J Med. 1987 Jan;82(1):20-8. doi: 10.1016/0002-9343(87)90372-x.
PubMed 2432783Zimetbaum P, Josephson ME. Evaluation of patients with palpitations. N Engl J Med. 1998 May 7;338(19):1369-73. doi: 10.1056/NEJM199805073381907. No abstract available.
PubMed 9571258
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the CarnationTM Ambulatory Monitoring Sternal ECG Patch System With a Conventional 24-Hour 7 Lead Holter Monitor Recorder
- ClinicalTrials.gov ID
- NCT04241692
- Acronym / sponsor ID
- Pro00013642
- Conditions
- Cardiac Arrhythmia, Syncope
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Children's National Research InstituteUniversity, hospital or other
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Mar 2023 (estimated)
- First posted
- 27 Jan 2020 (actual)
- 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 will be a comparison of two externally worn recording systems for documentation of cardiac arrhythmias in symptomatic patients or patients at risk for arrhythmia. Non-invasive documentation of cardiac arrhythmias can be done using the standard electrocardiogram (ECG). This has limitations given it is performed for only a 10 sec period. Alternative methods for making longer term recording have been developed. The standard device is the 24 hour 7-lead Holter monitor. Newer technology has simplified the hardware needed to make these longer term recordings, and incorporate a self-contained recording system in a patch that is applied over the patient's chest. Little is known comparing the sensitivity, specificity and recording noise / signal artifact between the older technology (standard 24-Hour Holter monitor) and the Patch electrode.
Detailed description
Objective: Comparison of two externally worn recording systems for documentation of cardiac arrhythmias in symptomatic patients or patients at risk for arrhythmia. Non-invasive documentation of cardiac arrhythmias can be done by attempting to take a snapshot view of a patient's cardiac rhythm using the standard electrocardiogram (ECG). This has limitations given it is performed for only a 10 sec period, and requires the patient to be symptomatic at the time of the recording. Therefore, the sensitivity of this technique is very low. Alternative methods for making longer term recording have been developed and used for decades. The standard device is the 24 hour 7-lead Holter monitor. These devises are large, restrict patient mobility and require cables to be connected between the applied skin ECG electrodes placed on the patient's chest and the recording device. Newer technology has simplified the hardware needed to make these longer term recordings, and incorporate a self-contained recording system in a patch that is applied over the patient's chest. These units allow for unlimited mobility, are significantly smaller, easier to wear and have eliminated the requirement for cables to connect the electrodes with the recording device. However, little is known comparing the sensitivity, specificity and recording noise / signal artifact between the older technology (standard 24-Hour Holter monitor) and the Patch electrode.
Specific Aims:
Aim 1: Comparison of Cardiac Arrhythmia Documentation between Standard 24-Hour Holter Monitor vs. Patch Monitor To evaluate the diagnostic yield for cardiac arrhythmias between the two recording systems.
The presence and frequency (qualitative and quantitative) of cardiac arrhythmias documented by each recording system with be compared. To allow for this type of comparison, each enrolled research subject with wear both systems simultaneously.
Aim 2: Comparison of Recording Quality between Standard 24-Hour Holter Monitor vs. Patch Monitor To evaluate percentage of time ECG signal quality is poor and uninterpretable.
Aim 3: Comparison of Comfortability Between Standard 24-HourHolter Monitor vs. Patch Monitor Recording Quality To evaluate level of patient's discomfort during the application of each recording system. Since both systems will be applied at the same time it may be hard for the research subject to rank the comfortability of the two systems. We will focus in this aim at more objective measures such as skin irritation under the recording electrodes, and frequency of time during which the skin electrodes come off the patient and require re-application.
Hypotheses:
Aim 1: Comparison of Cardiac Arrhythmia Documentation between Standard 24-Hour Holter Monitor vs. Patch Monitor We hypothesize that there will be no qualitative or quantitative difference in arrhythmia frequency between the two recording techniques, i.e. that both devices will detect all spontaneous arrhythmias with similar quantitative counts of ectopic beats (+/- 5%).
Aim 2: Comparison of Recording Quality between Standard 24-Hour Holter Monitor vs. Patch Monitor We hypothesize that recording quality will be better with the Patch Monitor since there are not 7 separately applied skin electrodes and cables connecting the electrodes with the recorder, resulting in a lower percent of poor ECG signal quality.
Aim 3: Comparison of Comfortability Between Standard 24-hour Holter Monitor vs. Patch Monitor Recording Quality We hypothesize that the degree of skin irritation and level of discomfort in the region of application will be less with the Patch Monitor. We hypothesize that the ECG leads will fall off from its site of application will be less with the Patch Monitor.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- To allow for this type of comparison, each enrolled research subject will wear both systems simultaneously
| Arm | Type | Receives |
|---|---|---|
| Application of Carnation Ambulatory Patch Monitoring System | Experimental | Device: CarnationTM Ambulatory Monitoring Sternal ECG Patch SystemThe patient will wear a Standard Holter Monitor and the CAM Patch system simultaneously for 24 hours. |
| Application Conventional 24-Hour Holter Monitor Recorder | Experimental | Device: Conventional 24-Hour 7 Lead Holter Monitor RecorderThe patient will wear a Standard Holter Monitor and the CAM Patch system simultaneously for 24 hours. |
Who may qualify
- Ages
- Up to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Any infant, child, adolescent, or young adult with one or more of the following:
Key exclusion criteria (1 listed)
- Any inflamed or friable skin over the anterior thorax and upper abdomen or a sternal incision 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarnationTM Ambulatory Monitoring Sternal ECG Patch SystemA newly developed cardiac rhythm monitoring system | Device | Application of Carnation Ambulatory Patch Monitoring System |
| Conventional 24-Hour 7 Lead Holter Monitor RecorderTraditional recordings made using a standard 24-hour Holter monitor. | Device | Application Conventional 24-Hour Holter Monitor Recorder |
Primary outcome
Difference in Cardiac Arrhythmia Detection Between Recording Systems
Time frame: 24 Hours
The presence (yes/no) and frequency of cardiac arrhythmias will be quantitated on each recording system for comparison
Difference in Signal Quality Between Recording Systems
Time frame: 24 Hours
We will quantitatively evaluate percentage of time signal quality is poor and uninterpretable with each recording system.
1 secondary outcome
Difference in Skin Discomfort Between Recording Systems
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 28 Jul 2022.
- BackgroundBigger JT Jr, Reiffel JA, Coromilas J. Ambulatory electrocardiography. In: Platia E, ed. Non-Pharmacologic Management of Cardiac Arrhythmias. Philadelphia: JB Lippincott, 1986:36-61.
- Background: 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.
- Background: PubMed 6702676Gibson TC, Heitzman MR. Diagnostic efficacy of 24-hour electrocardiographic monitoring for syncope. Am J Cardiol. 1984 Apr 1;53(8):1013-7. doi: 10.1016/0002-9149(84)90628-3.
- Background: PubMed 12114836Heilbron EL. Advances in modern electrocardiographic equipment for long-term ambulatory monitoring. Card Electrophysiol Rev. 2002 Sep;6(3):185-9. doi: 10.1023/a:1016322218490.
- Background: PubMed 363045Jonas S, Klein I, Dimant J. Importance of Holter monitoring in patients with periodic cerebral symptoms. Ann Neurol. 1977 May;1(5):470-4. doi: 10.1002/ana.410010511.
- Background: PubMed 2432783Kapoor WN, Cha R, Peterson JR, Wieand HS, Karpf M. Prolonged electrocardiographic monitoring in patients with syncope. Importance of frequent or repetitive ventricular ectopy. Am J Med. 1987 Jan;82(1):20-8. doi: 10.1016/0002-9343(87)90372-x.
- Background: PubMed 9571258Zimetbaum P, Josephson ME. Evaluation of patients with palpitations. N Engl J Med. 1998 May 7;338(19):1369-73. doi: 10.1056/NEJM199805073381907. No abstract available.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CarnationTM Ambulatory Monitoring Sternal ECG Patch System and Conventional 24-Hour 7 Lead Holter Monitor Recorder in people with Cardiac Arrhythmia and Syncope, run by Children's National Research Institute 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 5 inclusion and 1 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 28 Jul 2022. 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?
Results are not available in the source record.
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?
Difference in Cardiac Arrhythmia Detection Between Recording Systems (time frame: 24 Hours). The study lists 2 primary outcomes in all. 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 NCT04241692, 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 28 Jul 2022; AzTrials last refreshed its copy on 28 Oct 2026.