Atrial FibrillationNCT03657134
Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor
A study testing CoVa-2 Monitoring System in people with Atrial Fibrillation and Ventricular Tachycardia, run by NYU Langone Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation, Ventricular Tachycardia
- What is being tested?
- CoVa-2 Monitoring System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 28 Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
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.
- Conditions
- Atrial Fibrillation, Ventricular Tachycardia
- Being tested
- CoVa-2 Monitoring System
- Medical subject headings
- Atrial Fibrillation, Tachycardia, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoVa-2 Monitoring SystemDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: CoVa-2 Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 8 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start15 Nov 2018
- Primary completion28 Jul 2020
- Study completion28 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lior Jankelson, MD, PhD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03657134
- Sponsor's protocol ID
- 17-01618
- Status last verified
- Aug 2021
- First submitted
- 8 Aug 2018
- Last updated
- 22 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor
- ClinicalTrials.gov ID
- NCT03657134
- Acronym / sponsor ID
- 17-01618
- Conditions
- Atrial Fibrillation, Ventricular Tachycardia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 28 Jul 2020 (actual)
- Study completion
- 28 Jul 2020 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Posted 22 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EP Procedure | Experimental | Diagnostic Test: CoVa-2 Monitoring SystemPatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoVa-2 Monitoring SystemUpon 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. | Diagnostic test | EP Procedure |
Primary outcome
Average Change in Heart Rate (HR)
Time frame: 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)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lior Jankelson, MD, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoVa-2 Monitoring System in people with Atrial Fibrillation and Ventricular Tachycardia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Change in Heart Rate (HR) (time frame: Baseline, 8 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2021.