Status:
COMPLETED
Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH)
Lead Sponsor:
Zoll Medical Corporation
Conditions:
Heart Arrhythmia
Eligibility:
All Genders
21+ years
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 yea...
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- The following criteria will be used to include subjects in phase I portion of the study:
- Healthy male and female volunteers.
- Subjects older than 21 years of age.
- Subjects willing to wear the µCor device for up to 30 days.
- Subjects willing to answer weekly phone calls from the study staff.
- The following criteria will be used to include subjects in phase II portion of the study:
- Patients with a clinical indication for outpatient cardiac monitoring.
- Patients older than 21 years of age.
- Patients willing to wear the µCor device for up to 90 days.
- Patients willing to make monthly (30-, 60-, and 90-day) office visits during the study period.
- Patients willing to answer weekly phone calls regarding their health status.
- Exclusion Criteria:
- The following criteria will be used to exclude subjects from phases I and II portions of the study:
- Subjects reporting or planning to be pregnant.
- Subjects with any cardiac implantable electronic devices, including loop recorders.
- Subjects with a wearable cardioverter defibrillator.
- Subjects with Holter monitors, wearable event recorders, and other mobile cardiac telemetry devices.
- Subjects with any skin condition that would prevent them from wearing the µCor system.
- Subjects who are non-ambulatory.
- Subjects without adequate cellular transmission access that would prevent data download from the µCor device.
- Subjects participating in another clinical study.
- Subjects unable to give informed consent.
- Employees of ZOLL or their family members.
- Subjects traveling during the study participation period that prevents planned office visits and weekly phone calls from the study coordinator.
- Subjects expected to undergo a planned MRI exam during the participation period.
Exclusion
Key Trial Info
Start Date :
October 25 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 2 2020
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT04512703
Start Date
October 25 2018
End Date
August 2 2020
Last Update
June 3 2021
Active Locations (1)
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1
Medizinische Hochschule Hannover
Hanover, Germany