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

NCT ID: NCT05505136

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-30

Study Completion Date

2023-05-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

1. 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.
2. Follow up at 6 months will be determined for all patients to assess the impact of the medication change.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrhythmia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Arrhythmia Management System (AMS)

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* Those patients from the MAPS study that did not have medication changes.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zoll Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Steven Ringquist

Role: STUDY_CHAIR

Zoll Services LLC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cardiovascular Institute of Central Florida

Ocala, Florida, United States

Site Status

First Coast Heart & Vascular Center

Saint Augustine, Florida, United States

Site Status

Jackson Heart Clinic

Jackson, Mississippi, United States

Site Status

PharmaTex Research

Amarillo, Texas, United States

Site Status

Texas Cardiology Associates of Houston

Kingwood, Texas, United States

Site Status

CardioVoyage

McKinney, Texas, United States

Site Status

Dr. Daniel W. Gottlieb

Burien, Washington, United States

Site Status

St. Mary's Medical Center EP

Huntington, West Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

90D0255

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Assessment of Combined CCM and ICD Device in HFrEF
NCT05855135 ACTIVE_NOT_RECRUITING NA