N/A
Completed N=20
Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor
Atrial Fibrillation · Ventricular Tachycardia
Source: ClinicalTrials.gov NCT03657134 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: Average Change in Heart Rate (HR) — 6.5 beats per minute (bpm)
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change in Heart Rate (HR) |
6.5 | — |
| PRIMARY Average Change in Respiratory Rate (RR) |
3.8 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with arrhythmias and other cardiac conditions that are scheduled for EP procedures.
- Subject is over 22 years of age at the time of consenting
- Subject and/or legally authorized representative is willing to undergo the informed consent process prior to enrollment in the study
Exclusion Criteria
- Pregnant subjects
- Subjects who are participating in another clinical study that may affect the results of either study
- Subjects who are unwilling or unable to wear the sensor (and electrodes) for a period of up to 14 hours
- Subjects who are considered by the principle investigator to be medically unsuitable for study participation
Data sourced from ClinicalTrials.gov (NCT03657134). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.