Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients

NCT04754204 | Completed FDA Device

• 1 other identifier: 90D0234
• Study Type: observational
• Target: 585
• Locations: 1 country
• Sites: 20

Brief Summary

To determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness.

Conditions

Cardiac Arrhythmia

Keywords

cardiac; arrhythmia

Outcome Measures

Primary Outcomes (3)

• Biometric Data Associations to Arrhythmias

  MCT Data Sets

  30 days

• Biometric Data Associations to Subject-Reported Symptoms

  MCT Data Sets

  30 days

• Biometric Data Associations to Subject Wellness

  MCT Data Sets

  30 days

Secondary Outcomes (3)

• Clinician Use of Biometric Data Associations to Arrhythmias

  30 days

• Clinician Use of Biometric Data Associations to Subject-Reported Symptoms

  30 days

• Clinician Use of Biometric Data Associations to Wellness Status of Subject

  30 days

Study Arms (1)

Patients indicated for Mobile Cardiac Telemetry Monitoring

Patients indicated for Mobile Cardiac Telemetry Monitoring while meeting inclusion/exclusion criteria and enrolled in sequential manner.

Device: Arrhythmia Management System (AMS)

Interventions

Arrhythmia Management System (AMS) DEVICE

AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity and body posture.

Patients indicated for Mobile Cardiac Telemetry Monitoring

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, 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (20)

Comprehensive Cardiovascular Medical Group

Bakersfield, California, 93309, United States

Location

Cardiovascular Innovation and Research Center

Long Beach, California, 90813, United States

Location

Heartbeat Cardiovascular Medical Group

Los Angeles, California, 90027, United States

Location

Interventional Cardiology Group

West Hills, California, 91307, United States

Location

Flagler Hospital/Flagler Health

Jacksonville, Florida, 32086, United States

Location

Cardiovascular Institute of Central Florida

Ocala, Florida, 34476, United States

Location

First Coast Heart and Vascular Center

Saint Augustine, Florida, 32086, United States

Location

Cardiovascular Research of Northwest Indiana

Munster, Indiana, 46321, United States

Location

Cardiovascular Research of Northwest

Munster, Indiana, 46321, United States

Location

Jackson Heart Clinic

Jackson, Mississippi, 39216, United States

Location

Trinity Medical

Cheektowaga, New York, 14227, United States

Location

PMG Research of Wilmington

Wilmington, North Carolina, 28401, United States

Location

Erlanger Health System

Chattanooga, Tennessee, 37403, United States

Location

ClinicalTex Research LLC d/b/a PharmaTex Research

Amarillo, Texas, 79109, United States

Location

Texas Cardiology Associates of Houston

Kingwood, Texas, 77339, United States

Location

Heart Rhythm Specialists

McKinney, Texas, 75070, United States

Location

CardioVoyage

McKinney, Texas, 75071, United States

Location

Orion Medical Research

Pasadena, Texas, 77505, United States

Location

Daniel W. Gottlieb, MD, PS

Burien, Washington, 98166, United States

Location

St. Mary's Medical Center

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

• Ramu Perumal, PhD

  Zoll Services LLC

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 15, 2021
• Study Start: December 15, 2020
• Primary Completion: December 15, 2021
• Study Completion: December 15, 2021
• Last Updated: February 9, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (20)