Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH)

NCT04512703 | Completed Results FDA Device

• 1 other identifier: 90D0167
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Arrhythmia

Outcome Measures

Primary Outcomes (6)

• Logistics of Study Device Setup and Monitoring

  Logistics will be assessed by the number of subjects successfully fitted with a device that was able to transmit data to the remote server. Device Setup

  Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90

• Device Wear Time and Compliance

  Total number of days the device is worn at least once, in the devices indicated for long term wear in the heart arryhthmia group. These devices were worn during both Period 1 and Period 2, and the outcome measure was assessed irrespective of whether the device was being worn in Period 1 or Period 2.

  Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90

• Subject's Ability to Accurately Place Device

  Subject Training will be assessed by measuring the incidence of correct device placement. Correct device placement was assessed irrespective of whether the device was being worn in Period 1 or Period 2.

  Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90

• Device Data Transmission and Device Connectivity

  Count of subjects that had daily data transmission.

  Period 1 and Period 2

• Ability to Provide Timely Arrythmia Monitoring

  Timely arrythmia monitoring will be assessed by the mean time from arrythmia event trigger to publication of arrythmia report to investigator. Timing or arrhythmia monitoring reporting was assessed irrespective of whether the device was being worn in Period 1 or Period 2.

  Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90

• Documentation of Clinically Actionable Events.

  Assessed by the total number of clinical events documented including arrythmia symptoms, physician office visits, ER visits, hospitalizations, and mortality in both the healthy group and arrhythmia monitoring group. The number or clinical events documented was assessed irrespective of whether the device was being worn in Period 1 or Period 2.

  Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90

Secondary Outcomes (6)

• Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency

  Period 1: Start of device wear at Day 0 to Day 7

• Association of Device Recordings to Clinical Events

  Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90

• Device Recording Stability

  Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90

• Respiration Rate Front and Side Device Measurement Equivalency

  Period 1: Start of device wear at Day 0 to Day 7

• Activity Front and Side Device Measurement Equivalency

  Period 1: Start of device wear at Day 0 to Day 7

Study Arms (4)

Healthy Group

Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days.

Device: µCor

Arrhythmia Monitoring Group

Patients with a clinical indication for outpatient cardiac monitoring. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 90 days.

Device: µCor

Front Position Devices

All devices placed in the front position

Side Position Devices

All devices placed in the side position

Interventions

µCor DEVICE

Sensor Monitor for arrhythmia and other bio-metric markers

Arrhythmia Monitoring Group; Healthy Group

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers (21 years or older) and adult patients with a clinical indication for ambulatory outpatient cardiac monitoring.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zoll Medical Corporation: lead

Study Sites (1)

Medizinische Hochschule Hannover

Hanover, Germany

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mike Osz
• Organization: ZOLL Medical Corporation

mosz@zoll.com

4129683333

Study Officials

• Mike Osz

  Zoll Medical Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 90 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2020
• First Posted: August 13, 2020
• Study Start: October 25, 2018
• Primary Completion: August 2, 2020
• Study Completion: August 2, 2020
• Last Updated: June 3, 2021
• Results First Posted: June 3, 2021

Record last verified: 2021-06

Locations

DE (1)