Atrial Fibrillation, Ventricular Tachycardia
Conditions
Brief summary
Subjects will be consented to wear the CoVa-2 monitoring system prior to (baseline), during, and after an Electrophysiology Procedure (EP). During this time, the system will measure the following parameters from subjects: heart rate (HR), Heart Rate Variability (HRV), respiration rate (RR), and Cardiac Output (CO). Data will be retrospectively analyzed to determine if the system effectively operates under these conditions, and can effectively monitor subjects and allow them to be discharged early from the hospital. Subjects will not be measured while transferred in and out of the operating room. Approximate sample size is 20 subjects.
Interventions
DIAGNOSTIC_TESTCoVa-2 Monitoring System
Upon completion of EP procedure, CoVa-2 monitoring system will be applied until discharge. Data from the sensor will be sent to the Gateway and Cloud-based system and analyzed retrospectively.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with arrhythmias and other cardiac conditions that are scheduled for EP procedures. 2. Subject is over 22 years of age at the time of consenting 3. Subject and/or legally authorized representative is willing to undergo the informed consent process prior to enrollment in the study
Exclusion criteria
1. Pregnant subjects 2. Subjects who are participating in another clinical study that may affect the results of either study 3. Subjects who are unwilling or unable to wear the sensor (and electrodes) for a period of up to 14 hours 4. Subjects who are considered by the principle investigator to be medically unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Change in Heart Rate (HR) | 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. |
| Average Change in Respiratory Rate (RR) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | EP Procedure |
|---|---|
| Age, Continuous | 57 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Average Change in Heart Rate (HR)
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.
Time frame: Baseline, 8 Hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EP Procedure | Average Change in Heart Rate (HR) | 6.5 beats per minute (bpm) | Standard Deviation 0.3 |
Primary
Average Change in Respiratory Rate (RR)
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.
Time frame: Baseline, 8 Hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EP Procedure | Average Change in Respiratory Rate (RR) | 3.8 bpm | Standard Deviation 0.8 |