Trial Outcomes & Findings for Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor (NCT NCT03657134)

Last Updated: 2021-09-22

Results Overview

HR data is retrospectively analyzed from the CoVa-2 monitoring system, and the average change in HR (prior to the start of EP (baseline) to completion of EP (8 hours)) is reported.

Recruitment status

COMPLETED

Study phase

Target enrollment

20 participants

Primary outcome timeframe

Baseline, 8 Hours

Results posted on

2021-09-22

Participant Flow

Participant milestones

Participant milestones
Measure	EP Procedure Patient will continuously wear the CoVa TM 2 system until they are discharged for period of about 24 hours. During this period, data from the sensor will be sent to the Gateway and Cloud- based System, and then analyzed retrospectively. CoVa 2 Sensor: Upon completion of EP procedure, CoVa 2 sensor will be applied until discharge. Data from the sensor will be sent to the Gateway and Cloudbased system and analyzed retrospectively.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EP Procedure n=20 Participants Patient will continuously wear the CoVa TM 2 system until they are discharged for period of about 24 hours. During this period, data from the sensor will be sent to the Gateway and Cloud- based System, and then analyzed retrospectively. CoVa 2 Sensor: Upon completion of EP procedure, CoVa 2 sensor will be applied until discharge. Data from the sensor will be sent to the Gateway and Cloudbased system and analyzed retrospectively.
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 8 Hours

HR data is retrospectively analyzed from the CoVa-2 monitoring system, and the average change in HR (prior to the start of EP (baseline) to completion of EP (8 hours)) is reported.

Outcome measures

Outcome measures
Measure	EP Procedure n=20 Participants Patient will continuously wear the CoVa-2 system until they are discharged for period of about 24 hours. During this period, data from the sensor will be sent to the Gateway and Cloud-based System, and then analyzed retrospectively. CoVa-2 Sensor: Upon completion of EP procedure, CoVa 2-sensor will be applied until discharge.
Average Change in Heart Rate (HR)	6.5 beats per minute (bpm) Standard Deviation 0.3

PRIMARY outcome

Timeframe: Baseline, 8 Hours

RR data is retrospectively analyzed from the CoVa-2 monitoring system, and the average change in RR (prior to the start of EP (baseline) to completion of EP (8 hours)) is reported.

Outcome measures

Outcome measures
Measure	EP Procedure n=20 Participants Patient will continuously wear the CoVa-2 system until they are discharged for period of about 24 hours. During this period, data from the sensor will be sent to the Gateway and Cloud-based System, and then analyzed retrospectively. CoVa-2 Sensor: Upon completion of EP procedure, CoVa 2-sensor will be applied until discharge.
Average Change in Respiratory Rate (RR)	3.8 bpm Standard Deviation 0.8

Adverse Events

EP Procedure

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lior Jankelson, MD, PhD

NYU Langone Health

Phone: 212-263-7149

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place