Trial Outcomes & Findings for Feasibility Study of the µCor Heart Failure and Arrhythmia Management System (PATCH) (NCT NCT04512703)

NCT ID: NCT04512703

Last Updated: 2021-06-03

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 51 participants
• Primary outcome timeframe: Period 1: Start of device wear at Day 0 to Day 7 and Period 2: Day 8 to 90
• Results posted on: 2021-06-03

Participant Flow

An additional subject was enrolled beyond the protocol in the arrhythmia group.

Participant milestones

Measure	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. µCor: Sensor Monitor for arrhythmia and other bio-metric markers	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. µCor: Sensor Monitor for arrhythmia and other bio-metric markers
Within 7 Days From Start of Device Wear STARTED	6	45
Within 7 Days From Start of Device Wear Wore Front Position	6	45
Within 7 Days From Start of Device Wear Wore Side Position	6	45
Within 7 Days From Start of Device Wear COMPLETED	6	45
Within 7 Days From Start of Device Wear NOT COMPLETED	0	0
Between 7th and 90th Day of Device Wear STARTED	6	45
Between 7th and 90th Day of Device Wear Wore Side Position Device	3	23
Between 7th and 90th Day of Device Wear Wore Front Position Device	3	22
Between 7th and 90th Day of Device Wear COMPLETED	6	45
Between 7th and 90th Day of Device Wear NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Healthy Group n=6 Participants Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days. µCor: Sensor Monitor for arrhythmia and other bio-metric markers	Arrhythmia Monitoring Group n=45 Participants 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. µCor: Sensor Monitor for arrhythmia and other bio-metric markers	Total n=51 Participants Total of all reporting groups
Age, Continuous	35 years n=6 Participants	61 years n=45 Participants	58 years n=51 Participants
Sex: Female, Male Female	3 Participants n=6 Participants	23 Participants n=45 Participants	26 Participants n=51 Participants
Sex: Female, Male Male	3 Participants n=6 Participants	22 Participants n=45 Participants	25 Participants n=51 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Germany	6 participants n=6 Participants	45 participants n=45 Participants	51 participants n=51 Participants

PRIMARY outcome

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

Population: All devices in both Healthy and Arrythmia Monitoring Group were assessed for setup at the beginning of Period 1. Monitoring assessment was assessed during both Period 1 and Period 2. There was a total of 51 side position devices and 51 front position devices.

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

Outcome measures

Measure	Front Position Devices n=51 Participants Devices placed in the front position	Side Position Devices n=51 Participants Devices placed in the side position
Logistics of Study Device Setup and Monitoring Devices Assessed for Setup during Period 1	51 count of participants	51 count of participants
Logistics of Study Device Setup and Monitoring Devices Assessed for Monitoring during Period 1	51 count of participants	51 count of participants
Logistics of Study Device Setup and Monitoring Devices assessed for Monitoring during Period 2	22 count of participants	23 count of participants

PRIMARY outcome

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

Population: Devices on subjects in the arrythmia group that were allocated for 90 day wear were used in the assessment.

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.

Outcome measures

Measure	Front Position Devices n=22 Participants Devices placed in the front position	Side Position Devices n=23 Participants Devices placed in the side position
Device Wear Time and Compliance	68 Days Standard Deviation 29	54 Days Standard Deviation 36

PRIMARY outcome

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

Population: A position assessment and orientation placement was assessed for accuracy for all front and side devices.

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.

Outcome measures

Measure	Front Position Devices n=51 Participants Devices placed in the front position	Side Position Devices n=51 Participants Devices placed in the side position
Subject's Ability to Accurately Place Device	96 percentage of correct placements	96 percentage of correct placements

PRIMARY outcome

Timeframe: Period 1 and Period 2

Count of subjects that had daily data transmission.

Outcome measures

Measure	Front Position Devices n=51 Participants Devices placed in the front position	Side Position Devices n=51 Participants Devices placed in the side position
Device Data Transmission and Device Connectivity Devices Worn during Phase 1	51 count of participants	51 count of participants
Device Data Transmission and Device Connectivity Devices Worn during Phase 2	22 count of participants	23 count of participants

PRIMARY outcome

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

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.

Outcome measures

Measure	Front Position Devices n=22 Participants Devices placed in the front position	Side Position Devices n=23 Participants Devices placed in the side position
Ability to Provide Timely Arrythmia Monitoring	9.9 hours Standard Deviation 42.8	10.5 hours Standard Deviation 55.0

PRIMARY outcome

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

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.

Outcome measures

Measure	Front Position Devices n=51 Participants Devices placed in the front position	Side Position Devices n=51 Participants Devices placed in the side position
Documentation of Clinically Actionable Events.	29 documented clinical events	42 documented clinical events

SECONDARY outcome

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

Population: Includes both healthy and arrhythmia monitoring groups

The TFC measurement was compared between front and side placed devices. TFC is a unitless measurement that encompasses the degree of reflected radar waves in the lung taken by the study device. Higher TFC is indicative of increased fluid, whereas lower TFC is indicative of decreased fluid.

Outcome measures

Measure	Front Position Devices n=51 Participants Devices placed in the front position	Side Position Devices n=51 Participants Devices placed in the side position
Thoracic Fluid Content (TFC) Front and Side Device Measurement Equivalency	23.4 units Standard Deviation 7.3	24.0 units Standard Deviation 9.5

SECONDARY outcome

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

Population: Devices in all subjects were assessed for arrythmia/symptom associations. The healthy and arrhthmia monitoring groups were combined for this outcome measure as the study investigated whether documented symptoms were associated with ECG arrhythmia regardless of group allocation.

Device recordings were assessed and compared to clinical events in both the healthy group and arrhythmia monitoring group. Device recording associations were assessed irrespective of whether the device was being worn in Period 1 or Period 2.

Outcome measures

Measure	Front Position Devices n=51 Participants Devices placed in the front position	Side Position Devices Devices placed in the side position
Association of Device Recordings to Clinical Events	5 Arrhythmias associated with symptoms	—

SECONDARY outcome

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

Population: Includes both healthy and arrhythmia monitoring groups

Device recording stability was assessed through the heart rate coefficient of variation in both front and side placed devices. Stability was assessed irrespective of whether the device was being worn in Period 1 or Period 2.

Outcome measures

Measure	Front Position Devices n=51 Participants Devices placed in the front position	Side Position Devices n=51 Participants Devices placed in the side position
Device Recording Stability	0.48 Percent Coefficient of Variation Standard Deviation .47	0.41 Percent Coefficient of Variation Standard Deviation .20

SECONDARY outcome

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

Population: Includes both healthy and arrhythmia monitoring groups

Respiration rates were compared between front and side placed devices. The outcome was measured only during Period 1 when both front and side devices were worn simultaneously.

Outcome measures

Measure	Front Position Devices n=51 Participants Devices placed in the front position	Side Position Devices n=51 Participants Devices placed in the side position
Respiration Rate Front and Side Device Measurement Equivalency	16.9 respirations per minute Standard Deviation 4.4	16.9 respirations per minute Standard Deviation 4.4

SECONDARY outcome

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

Population: Includes both healthy and arrhythmia monitoring groups

Activity counts were compared between front and side devices.

Outcome measures

Measure	Front Position Devices n=51 Participants Devices placed in the front position	Side Position Devices n=51 Participants Devices placed in the side position
Activity Front and Side Device Measurement Equivalency	981 activity counts Standard Deviation 934	1007 activity counts Standard Deviation 989

SECONDARY outcome

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

Population: Includes both healthy and arrhythmia monitoring groups

Sleep angle was compared between front and side devices.

Outcome measures

Measure	Front Position Devices n=51 Participants Devices placed in the front position	Side Position Devices n=51 Participants Devices placed in the side position
Sleep Angle Front and Side Device Measurement Equivalency	2.5 degrees Standard Deviation 12.8	2.3 degrees Standard Deviation 12.2

Adverse Events

Healthy Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Arrhythmia Monitoring Group

Serious events: 0 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Healthy Group n=6 participants at risk Healthy male and female volunteers. Subjects older than 21 years of age. Subjects to wear the µCor device for up to 30 days. µCor: Sensor Monitor for arrhythmia and other bio-metric markers	Arrhythmia Monitoring Group n=45 participants at risk 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. µCor: Sensor Monitor for arrhythmia and other bio-metric markers
Skin and subcutaneous tissue disorders Skin Irritation	100.0% 6/6 • Adverse events were collected from enrollment of the subject in the study to the date the subject completed the study, up to 90 days. Adverse evenst were defined in the study as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs in subjects, users, or other persons whether or not related to the study device. Serious adverse events were defined per study protocol.	93.3% 42/45 • Adverse events were collected from enrollment of the subject in the study to the date the subject completed the study, up to 90 days. Adverse evenst were defined in the study as any untoward medical occurrence, unintended disease or injury or any untoward clinical signs in subjects, users, or other persons whether or not related to the study device. Serious adverse events were defined per study protocol.

Additional Information

Mike Osz

ZOLL Medical Corporation

Phone: 4129683333

Email: mosz@zoll.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any proposed publication relating to the research conducted under this protocol will be submitted to the sponsor for review at least 45 days prior to submission for publication. The publication may be delayed for an additional period of up to 90 days for intellectual property considerations or until all confidential information has been eliminated from the publication(s) and sponsor has approved the publication. It may be determined by the sponsor that no data from this study will be published.
• Publication restrictions are in place

Restriction type: OTHER