Clinical trial NCT04241692: Comparative Study of the Sternal Patch System With a Conventional Holter Recorder
Official title: Comparative Study of the CarnationTM Ambulatory Monitoring Sternal ECG Patch System With a Conventional 24-Hour 7 Lead Holter Monitor Recorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrhythmia
Syncope
Lead sponsor: Children's National Research Institute
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 50
Sex: ALL
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To allow for this type of comparison, each enrolled research subject will wear both systems simultaneously
Primary purpose: DIAGNOSTIC

Brief 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). 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.

Eligibility criteria: Inclusion Criteria:

* Any infant, child, adolescent, or young adult with one or more of the following:

  1. Syncope
  2. Pre-syncope
  3. Palpitations
  4. Management of a known or suspected cardiac arrhythmia

Exclusion Criteria:

* Any inflamed or friable skin over the anterior thorax and upper abdomen or a sternal incision within 3 months from the date of enrollment

Primary outcomes:
measure: Difference in Cardiac Arrhythmia Detection Between Recording Systems
timeFrame: 24 Hours
measure: Difference in Signal Quality Between Recording Systems
timeFrame: 24 Hours
Secondary outcomes:
measure: Difference in Skin Discomfort Between Recording Systems
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Washington
country: United States
facility: Children's National Hospital
state: District of Columbia
Study officials:
References:
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citation: Kapoor 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.
citation: Zimetbaum 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.