Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in PatientS Wearing a Novel Device With Biometric Based Medications Changes

NCT05505136 | Completed FDA Device

• 1 other identifier: 90D0255
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 8

Brief Summary

To determine the associations among biometric data and previously reported medication changes in the original MAPS study

Conditions

Cardiac Arrhythmia

Outcome Measures

Primary Outcomes (7)

• Association Between Arrhythmia Biometric and Medication Change

  Clinical Case Report Form

  1 Day

• Association Between Subject-Reported Symptom Biometric and Medication Change

  Clinical Case Report Form

  1 Day

• Association Between Subject Wellness Biometric and Medication Change

  Clinical Case Report Form

  1 Day

• Association Between Subject Adverse Event and Medication Change

  Clinical Case Report Form

  1 Day

• Association Between Subject Status and Medication Change

  Clinical Case Report Form

  1 Day

• Association Between Subject Hospital Events and Medication Change

  Clinical Case Report Form

  1 Day

• Association Between Subject Clinical Events and Medication Change

  Clinical Case Report Form

  1 Day

Study Arms (1)

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.

Device: Arrhythmia Management System (AMS)

Interventions

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.

MAPS Study Patients with Medication Change Reported

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects who completed the MAPS study with a reported medication change based wholly or in part on biometric information.

You may qualify if:

• those that completed the MAPS study and that had medication changes based wholly or in part on biometric information.

You may not qualify if:

• Those patients from the MAPS study that did not have medication changes.

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (8)

Cardiovascular Institute of Central Florida

Ocala, Florida, 34471, United States

Location

First Coast Heart & Vascular Center

Saint Augustine, Florida, 32086, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

PharmaTex Research

Amarillo, Texas, 79109, United States

Location

Texas Cardiology Associates of Houston

Kingwood, Texas, 77339, United States

Location

CardioVoyage

McKinney, Texas, 75071, United States

Location

Dr. Daniel W. Gottlieb

Burien, Washington, 98166, United States

Location

St. Mary's Medical Center EP

Huntington, West Virginia, 25702, United States

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Steven Ringquist

  Zoll Services LLC

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 17, 2022
• Study Start: August 30, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 15, 2023
• Last Updated: June 18, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)