Cardiac ArrhythmiaMAPS IINCT05505136
Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based Medications Changes
An observational study of Cardiac Arrhythmia, run by Zoll Medical Corporation at 8 sites in United States.
Trial summary
To determine the associations among biometric data and previously reported medication changes in the original MAPS study 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
- 62 participants
- Where
- 8 sitesUnited States
- Study dates
- 30 Aug 2022to 15 May 2023
- 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 who completed the MAPS study with a reported medication change based wholly or in part on biometric information.
Who may be able to join
- those that completed the MAPS study and that had medication changes based wholly or in part on biometric information.
Who cannot join
- Those patients from the MAPS study that did not have medication changes.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
PharmaTex Research
Amarillo, Texas, 79109
Dr. Daniel W. Gottlieb
Burien, Washington, 98166
St. Mary's Medical Center EP
Huntington, West Virginia, 25702
Jackson Heart Clinic
Jackson, Mississippi, 39216
Texas Cardiology Associates of Houston
Kingwood, Texas, 77339
CardioVoyage
McKinney, Texas, 75071
Cardiovascular Institute of Central Florida
Ocala, Florida, 34471
First Coast Heart & Vascular Center
Saint Augustine, Florida, 32086
About this study
Official title: Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based
To determine the associations among biometric data and previously reported medication changes in the original MAPS study
Read the detailed description
- Each center that previously reported making a medication change in a MAPS patient based on biometric information will complete a case report form detailing the rhythm, symptom, medication and dosage change, and which biometric(s) were used to make this decision.
- Follow up at 6 months will be determined for all patients to assess the impact of the medication change.
- Conditions
- Cardiac Arrhythmia
- Being tested
- Arrhythmia Management System (AMS)
- 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
Retrospective collection of data related to subjects who participated in the MAPS 90D0234 study and had a medication change reported will wearing the AMS device.
| Study group | Role | What they receive |
|---|---|---|
| MAPS Study Patients with Medication Change Reported | No intervention will be administered. This is a retrospective study of the patients who participating in the MAPS Protocol 90D0234 completed in 2021. Patients who had a medication change reported in that study are the focus of this study MAPS II 90D0255. Receives: Device: Arrhythmia Management System (AMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association Between Arrhythmia Biometric and Medication Change
Clinical Case Report Form
Measured: 1 Day
Association Between Subject-Reported Symptom Biometric and Medication Change
Clinical Case Report Form
Measured: 1 Day
Association Between Subject Wellness Biometric and Medication Change
Clinical Case Report Form
Measured: 1 Day
Association Between Subject Adverse Event and Medication Change
Clinical Case Report Form
Measured: 1 Day
Association Between Subject Status and Medication Change
Clinical Case Report Form
Measured: 1 Day
Association Between Subject Hospital Events and Medication Change
Clinical Case Report Form
Measured: 1 Day
Association Between Subject Clinical Events and Medication Change
Clinical Case Report Form
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start30 Aug 2022
- Primary completion1 Mar 2023
- Study completion15 May 2023
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
- Retrospective
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zoll Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Steven Ringquist, Study chair, Zoll Services LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05505136
- Sponsor's protocol ID
- 90D0255
- Acronym
- MAPS II
- Status last verified
- Jun 2023
- First submitted
- 12 Aug 2022
- Last updated
- 18 Jun 2023
- 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 18 Jun 2023. 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 With Biometric Based
- ClinicalTrials.gov ID
- NCT05505136
- Acronym / sponsor ID
- MAPS II / 90D0255
- Conditions
- Cardiac Arrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Zoll Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 17 Aug 2022 (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 and previously reported medication changes in the original MAPS study
Detailed description
- Each center that previously reported making a medication change in a MAPS patient based on biometric information will complete a case report form detailing the rhythm, symptom, medication and dosage change, and which biometric(s) were used to make this decision.
- Follow up at 6 months will be determined for all patients to assess the impact of the medication change.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MAPS Study Patients with Medication Change Reported | – | Device: Arrhythmia Management System (AMS)No intervention will be administered. This is a retrospective study of the patients who participating in the MAPS Protocol 90D0234 completed in 2021. Patients who had a medication change reported in that study are the focus of this study MAPS II 90D0255. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult subjects who completed the MAPS study with a reported medication change based wholly or in part on biometric information.
Key inclusion criteria (1 listed)
- those that completed the MAPS study and that had medication changes based wholly or in part on biometric information.
Key exclusion criteria (1 listed)
- Those patients from the MAPS study that did not have medication changes.
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)Retrospective collection of data related to subjects who participated in the MAPS 90D0234 study and had a medication change reported will wearing the AMS device. | Device | MAPS Study Patients with Medication Change Reported |
Primary outcome
Association Between Arrhythmia Biometric and Medication Change
Time frame: 1 Day
Clinical Case Report Form
Association Between Subject-Reported Symptom Biometric and Medication Change
Time frame: 1 Day
Clinical Case Report Form
Association Between Subject Wellness Biometric and Medication Change
Time frame: 1 Day
Clinical Case Report Form
Association Between Subject Adverse Event and Medication Change
Time frame: 1 Day
Clinical Case Report Form
Association Between Subject Status and Medication Change
Time frame: 1 Day
Clinical Case Report Form
Association Between Subject Hospital Events and Medication Change
Time frame: 1 Day
Clinical Case Report Form
Association Between Subject Clinical Events and Medication Change
Time frame: 1 Day
Clinical Case Report Form
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 18 Jun 2023.
- 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.
Steven Ringquist study chair
Zoll Services LLC
8 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 8 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 1 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: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
Association Between Arrhythmia Biometric and Medication Change (time frame: 1 Day). The study lists 7 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 18 Jun 2023.