Cardiac ArrhythmiaMAPSNCT04754204
Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients
An observational study of Cardiac Arrhythmia, run by Zoll Medical Corporation at 20 sites in United States.
Trial summary
To determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- What is being tested?
- Arrhythmia Management System (AMS)
- Type of treatment
- Medical device
- How many people
- 585 participants
- Where
- 20 sitesUnited States
- Study dates
- 15 Dec 2020to 15 Dec 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult subjects, 21 years or older who: 1. Require mobile cardiac telemetry monitoring for the detection of non-lethal cardiac arrhythmias 2. Are without any cardiac implantable electronic devices, including loop recorders 3. Are without wearable cardioverter defibrillator 4. Are without Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time 5. Are not currently hospitalized 6. Do not have any skin condition that would prevent them from wearing the AMS device 7. Are not non-ambulatory 8. Are not reporting to be pregnant 9. Are not participating in another clinical study
Who may be able to join
- Subjects who require monitoring for non-lethal cardiac arrhythmias
- Subjects who have an indication for mobile cardiac telemetry (MCT) monitoring
- Subjects 21 years of age or older
Who cannot join
- Subjects with an implantable cardiac device such as left ventricular assistive device, pacemaker, implanted cardioverter defibrillator (ICD), cardiac resynchronization therapy device, subcutaneous ICD's, pressure monitors and loop monitors
- Subjects with wearable cardioverter defibrillator, Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time
- Subjects currently hospitalized
- Subjects with a skin condition preventing them from wearing the AMS device
- Subjects who are non-ambulatory
- Subjects who are self-reporting to be pregnant
- Subjects participating in another study
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
ClinicalTex Research LLC d/b/a PharmaTex Research
Amarillo, Texas, 79109
Comprehensive Cardiovascular Medical Group
Bakersfield, California, 93309
Daniel W. Gottlieb, MD, PS
Burien, Washington, 98166
Erlanger Health System
Chattanooga, Tennessee, 37403
Trinity Medical
Cheektowaga, New York, 14227
St. Mary's Medical Center
Huntington, West Virginia, 25702
Jackson Heart Clinic
Jackson, Mississippi, 39216
Flagler Hospital/Flagler Health
Jacksonville, Florida, 32086
Texas Cardiology Associates of Houston
Kingwood, Texas, 77339
Cardiovascular Innovation and Research Center
Long Beach, California, 90813
Heartbeat Cardiovascular Medical Group
Los Angeles, California, 90027
Heart Rhythm Specialists
McKinney, Texas, 75070
CardioVoyage
McKinney, Texas, 75071
Cardiovascular Research of Northwest Indiana
Munster, Indiana, 46321
Cardiovascular Research of Northwest
Munster, Indiana, 46321
Cardiovascular Institute of Central Florida
Ocala, Florida, 34476
Orion Medical Research
Pasadena, Texas, 77505
First Coast Heart and Vascular Center
Saint Augustine, Florida, 32086
Interventional Cardiology Group
West Hills, California, 91307
PMG Research of Wilmington
Wilmington, North Carolina, 28401
About this study
Official title: Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients Wearing a Novel Device
To determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness.
Read the detailed description
The Arrhythmia Management System records rhythm, heart rate, subject-reported symptoms and multiple parameters that include respiration rate, activity and body posture. These biometric data could provide clinicians better insight into the context of the detected arrhythmias, subject-reported symptoms and wellness status. Hence, the purpose of the study to determine the associations among biometric data, arrhythmias, symptoms and subject wellness.
- Conditions
- Cardiac Arrhythmia
- Being tested
- Arrhythmia Management System (AMS)
- Keywords
- cardiac, arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arrhythmia Management System (AMS)Device
AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity and body posture.
| Study group | Role | What they receive |
|---|---|---|
| Patients indicated for Mobile Cardiac Telemetry Monitoring | Patients indicated for Mobile Cardiac Telemetry Monitoring while meeting inclusion/exclusion criteria and enrolled in sequential manner. Receives: Device: Arrhythmia Management System (AMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biometric Data Associations to Arrhythmias
MCT Data Sets
Measured: 30 days
Biometric Data Associations to Subject-Reported Symptoms
MCT Data Sets
Measured: 30 days
Biometric Data Associations to Subject Wellness
MCT Data Sets
Measured: 30 days
Secondary outcomes (3)
Clinician Use of Biometric Data Associations to Arrhythmias
Clinical Case Report Forms
Measured: 30 days
Clinician Use of Biometric Data Associations to Subject-Reported Symptoms
Clinical Case Report Forms
Measured: 30 days
Clinician Use of Biometric Data Associations to Wellness Status of Subject
Clinical Case Report Forms
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2021
- Study start15 Dec 2020
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ramu Perumal, PhD, Study chair, Zoll Services LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04754204
- Sponsor's protocol ID
- 90D0234
- Acronym
- MAPS
- Status last verified
- Feb 2022
- First submitted
- 9 Feb 2021
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients Wearing a Novel Device
- ClinicalTrials.gov ID
- NCT04754204
- Acronym / sponsor ID
- MAPS / 90D0234
- Conditions
- Cardiac Arrhythmia
- Keywords
- cardiac, arrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 585 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 15 Feb 2021 (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.
To determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness.
Detailed description
The Arrhythmia Management System records rhythm, heart rate, subject-reported symptoms and multiple parameters that include respiration rate, activity and body posture. These biometric data could provide clinicians better insight into the context of the detected arrhythmias, subject-reported symptoms and wellness status. Hence, the purpose of the study to determine the associations among biometric data, arrhythmias, symptoms and subject wellness.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients indicated for Mobile Cardiac Telemetry Monitoring | – | Device: Arrhythmia Management System (AMS)Patients indicated for Mobile Cardiac Telemetry Monitoring while meeting inclusion/exclusion criteria and enrolled in sequential manner. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects, 21 years or older who: 1. Require mobile cardiac telemetry monitoring for the detection of non-lethal cardiac arrhythmias 2. Are without any cardiac implantable electronic devices, including loop recorders 3. Are without wearable cardioverter defibrillator 4. Are without Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time 5. Are not currently hospitalized 6. Do not have any skin condition that would prevent them from wearing the AMS device 7. Are not non-ambulatory 8. Are not reporting to be pregnant 9. Are not participating in another clinical study
Key inclusion criteria (3 listed)
- Subjects who require monitoring for non-lethal cardiac arrhythmias
- Subjects who have an indication for mobile cardiac telemetry (MCT) monitoring
- Subjects 21 years of age or older
Key exclusion criteria (7 listed)
- Subjects with an implantable cardiac device such as left ventricular assistive device, pacemaker, implanted cardioverter defibrillator (ICD), cardiac resynchronization therapy device, subcutaneous ICD's, pressure monitors and loop monitors
- Subjects with wearable cardioverter defibrillator, Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices at the same time
- Subjects currently hospitalized
- Subjects with a skin condition preventing them from wearing the AMS device
- Subjects who are non-ambulatory
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 |
|---|---|---|
| Arrhythmia Management System (AMS)AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity and body posture. | Device | Patients indicated for Mobile Cardiac Telemetry Monitoring |
Primary outcome
Biometric Data Associations to Arrhythmias
Time frame: 30 days
MCT Data Sets
Biometric Data Associations to Subject-Reported Symptoms
Time frame: 30 days
MCT Data Sets
Biometric Data Associations to Subject Wellness
Time frame: 30 days
MCT Data Sets
3 secondary outcomes
Clinician Use of Biometric Data Associations to Arrhythmias
Time frame: 30 days
Clinician Use of Biometric Data Associations to Subject-Reported Symptoms
Time frame: 30 days
Clinician Use of Biometric Data Associations to Wellness Status of Subject
Time frame: 30 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 9 Feb 2022.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrhythmia
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Enrolling by invitation
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms) Using Commercial Off-The-Shelf (COTS) Catheters
Ventricular Arrhythmia
Enrolling by invitation
EDEN Intracardiac Electrogram Recording and Classifying System
Ventricular Arrhythmia
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.
Ramu Perumal, PhD study chair
Zoll Services LLC
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by Zoll Medical Corporation at 20 sites 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 3 inclusion and 7 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 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites 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?
Biometric Data Associations to Arrhythmias (time frame: 30 days). The study lists 3 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 9 Feb 2022.