Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EP Procedure | Experimental | Patient will continuously wear the CoVa-2 monitoring system until they are discharged. During this period, data from the sensor will be sent to the Gateway and Cloud-based System, and then analyzed retrospectively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CoVa-2 Monitoring System | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 8 Hours |
| 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. | Baseline, 8 Hours |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lior Jankelson, MD, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2018 | Aug 26, 2021 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | beats per minute (bpm) | Baseline, 8 Hours |
|
|
| ||||||||||||||||||||||||||
| 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. | Posted | Mean | Standard Deviation | bpm | Baseline, 8 Hours |
|
|
1 Week
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lior Jankelson, MD, PhD | NYU Langone Health | 212-263-7149 | Lior.Jankelson@nyulangone.org |
| Prot_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D017180 | Tachycardia, Ventricular |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013610 | Tachycardia |
| D000075224 | Cardiac Conduction System Disease |
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|