Clinical trial NCT04754204: Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients
Official title: Mobile Cardiac Telemetry and Advanced Multi-Parameter Monitoring in Patients Wearing a Novel Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrhythmia
Keywords: cardiac
arrhythmia
Lead sponsor: Zoll Medical Corporation
Sponsor class: INDUSTRY
First posted: 2021-02-15
Enrollment: 585
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Biometric Data Associations to Arrhythmias
timeFrame: 30 days
measure: Biometric Data Associations to Subject-Reported Symptoms
timeFrame: 30 days
measure: Biometric Data Associations to Subject Wellness
timeFrame: 30 days
Secondary outcomes:
measure: Clinician Use of Biometric Data Associations to Arrhythmias
timeFrame: 30 days
measure: Clinician Use of Biometric Data Associations to Subject-Reported Symptoms
timeFrame: 30 days
measure: Clinician Use of Biometric Data Associations to Wellness Status of Subject
timeFrame: 30 days
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Comprehensive Cardiovascular Medical Group
state: California
city: Long Beach
country: United States
facility: Cardiovascular Innovation and Research Center
state: California
city: Los Angeles
country: United States
facility: Heartbeat Cardiovascular Medical Group
state: California
city: West Hills
country: United States
facility: Interventional Cardiology Group
state: California
city: Jacksonville
country: United States
facility: Flagler Hospital/Flagler Health
state: Florida
city: Ocala
country: United States
facility: Cardiovascular Institute of Central Florida
state: Florida
city: Saint Augustine
country: United States
facility: First Coast Heart and Vascular Center
state: Florida
city: Munster
country: United States
facility: Cardiovascular Research of Northwest Indiana
state: Indiana
city: Munster
country: United States
facility: Cardiovascular Research of Northwest
state: Indiana
city: Jackson
country: United States
facility: Jackson Heart Clinic
state: Mississippi
city: Cheektowaga
country: United States
facility: Trinity Medical
state: New York
city: Wilmington
country: United States
facility: PMG Research of Wilmington
state: North Carolina
city: Chattanooga
country: United States
facility: Erlanger Health System
state: Tennessee
city: Amarillo
country: United States
facility: ClinicalTex Research LLC d/b/a PharmaTex Research
state: Texas
city: Kingwood
country: United States
facility: Texas Cardiology Associates of Houston
state: Texas
city: McKinney
country: United States
facility: Heart Rhythm Specialists
state: Texas
city: McKinney
country: United States
facility: CardioVoyage
state: Texas
city: Pasadena
country: United States
facility: Orion Medical Research
state: Texas
city: Burien
country: United States
facility: Daniel W. Gottlieb, MD, PS
state: Washington
city: Huntington
country: United States
facility: St. Mary's Medical Center
state: West Virginia
Study officials:
affiliation: Zoll Services LLC
name: Ramu Perumal, PhD
role: STUDY_CHAIR
References: