Ignite Creation Date:
2024-05-06 @ 3:04 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04512703
Status:
COMPLETED
Last Update Posted:
2021-06-03
First Post:
2020-07-31
Brief Title:
Feasibility Study of the µCor Heart Failure and Arrhythmia Management System PATCH
Sponsor:
Zoll Medical Corporation
Organization:
Zoll Medical Corporation
Study Overview
Official Title:
Ambulatory Remote Patient Monitoring With the µCor Heart Failure and Arrhythmia Management System PATCH Feasibility Study
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PATCH
Brief Summary:
Prospective non-interventional feasibility study 8 months from start of screening to finishing the study Multi-center study with a maximum of 8 centers in Europe Health adult volunteers 21 years or older and adult patients with a clinical indication for ambulatory outpatient cardiac monitoring
To observe the feasibility of remotely monitoring patients with the novel µCor Heart Failure and Arrhythmia Management System µCor system that non-invasively captures thoracic fluid content electrocardiogram heart rate respiratory rate activity and body posture tory outpatient cardiac monitoring
To observe the feasibility of remotely monitoring patients with the novel µCor Heart Failure and Arrhythmia Management System µCor system that non-invasively captures thoracic fluid content electrocardiogram heart rate respiratory rate activity and body posture tory outpatient cardiac monitoring
Detailed Description:
The study will consist of two phases Phase I of the study will enroll 6 healthy volunteers who have no indication for remote cardiac monitoring Subjects are required to participate in the study for 30 days
Phase II of the study will enroll up to 44 patients indicated for outpatient cardiac monitoring and will participate in the study for up to 90 days
All subjects will wear the device in two locations one along the left midaxillary line and the other along the left midclavicular line for the first seven days
Thereafter for the remainder of the study half the enrolled subjects will only wear the device in the left midclavicular position and the other half will wear the device in the left midaxillary position Subjects will use a diary to keep a daily log their activities of daily living phase I or a log of any symptoms related to heart rhythm abnormalities and heart failure phase II
Data will be acquired with the µCor system and wirelessly transmitted daily to a remote server for processing generating thoracic fluid content ECG heart rate respiration rate activity and posture measurements Investigators will have access only to ECG data
Study staff will make weekly phone calls to subjects and record any new clinically actionable events Patients will have monthly office visits At the end of 30 days phase I or 90 days phase II patients will end wear and will complete the study follow-up questionnaire
The study will enroll a maximum of 50 subjects Six healthy volunteers will be enrolled for phase I of the study Remaining 44 subjects will be enrolled for phase II and will have an indication of outpatient cardiac monitoring
Phase II of the study will enroll up to 44 patients indicated for outpatient cardiac monitoring and will participate in the study for up to 90 days
All subjects will wear the device in two locations one along the left midaxillary line and the other along the left midclavicular line for the first seven days
Thereafter for the remainder of the study half the enrolled subjects will only wear the device in the left midclavicular position and the other half will wear the device in the left midaxillary position Subjects will use a diary to keep a daily log their activities of daily living phase I or a log of any symptoms related to heart rhythm abnormalities and heart failure phase II
Data will be acquired with the µCor system and wirelessly transmitted daily to a remote server for processing generating thoracic fluid content ECG heart rate respiration rate activity and posture measurements Investigators will have access only to ECG data
Study staff will make weekly phone calls to subjects and record any new clinically actionable events Patients will have monthly office visits At the end of 30 days phase I or 90 days phase II patients will end wear and will complete the study follow-up questionnaire
The study will enroll a maximum of 50 subjects Six healthy volunteers will be enrolled for phase I of the study Remaining 44 subjects will be enrolled for phase II and will have an indication of outpatient cardiac monitoring
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None