Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the associations among biometric data, arrhythmias, subject-reported symptoms and subject wellness.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients indicated for Mobile Cardiac Telemetry Monitoring | Patients indicated for Mobile Cardiac Telemetry Monitoring while meeting inclusion/exclusion criteria and enrolled in sequential manner. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arrhythmia Management System (AMS) | Device | AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity and body posture. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Use of Biometric Data Associations to Arrhythmias | Clinical Case Report Forms | 30 days |
| Clinician Use of Biometric Data Associations to Subject-Reported Symptoms | Clinical Case Report Forms |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Adult subjects, 21 years or older who:
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ramu Perumal, PhD | Zoll Services LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cardiovascular Medical Group | Bakersfield | California | 93309 | United States | ||
| Cardiovascular Innovation and Research Center |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 30 days |
| Clinician Use of Biometric Data Associations to Wellness Status of Subject | Clinical Case Report Forms | 30 days |
| Long Beach |
| California |
| 90813 |
| United States |
| Heartbeat Cardiovascular Medical Group | Los Angeles | California | 90027 | United States |
| Interventional Cardiology Group | West Hills | California | 91307 | United States |
| Flagler Hospital/Flagler Health | Jacksonville | Florida | 32086 | United States |
| Cardiovascular Institute of Central Florida | Ocala | Florida | 34476 | United States |
| First Coast Heart and Vascular Center | Saint Augustine | Florida | 32086 | United States |
| Cardiovascular Research of Northwest Indiana | Munster | Indiana | 46321 | United States |
| Cardiovascular Research of Northwest | Munster | Indiana | 46321 | United States |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | United States |
| Trinity Medical | Cheektowaga | New York | 14227 | United States |
| PMG Research of Wilmington | Wilmington | North Carolina | 28401 | United States |
| Erlanger Health System | Chattanooga | Tennessee | 37403 | United States |
| ClinicalTex Research LLC d/b/a PharmaTex Research | Amarillo | Texas | 79109 | United States |
| Texas Cardiology Associates of Houston | Kingwood | Texas | 77339 | United States |
| Heart Rhythm Specialists | McKinney | Texas | 75070 | United States |
| CardioVoyage | McKinney | Texas | 75071 | United States |
| Orion Medical Research | Pasadena | Texas | 77505 | United States |
| Daniel W. Gottlieb, MD, PS | Burien | Washington | 98166 | United States |
| St. Mary's Medical Center | Huntington | West Virginia | 25702 | United States |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided