Cardiac ArrhythmiaNCT02040675
Use of NAVA-catheter Positioning Screen to Identify Different Cardiac Arrhythmias
An observational study of Cardiac Arrhythmia, run by ProMedica Health System at 1 site in United States.
Trial summary
The purpose of this study is to validate a novel method of diagnosing arrhythmias using the NAVA catheter-positioning screen in patients who have a NAVA catheter in place. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrhythmia
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: The population will be a convenience sample of adults with various arrhythmias who are scheduled to undergo an electrophysiology study and-or ablation (EPSA) under general anesthesia (GETA) at The Toledo Hospital.
Who may be able to join
- Cardiac arrhythmia
Who cannot join
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to validate a novel method of diagnosing arrhythmias using the NAVA catheter-positioning screen in patients who have a NAVA catheter in place.
Read the detailed description
The population will be a convenience sample of adults with various arrhythmias who are scheduled to undergo an electrophysiology study and-or ablation (EPSA) under general anesthesia (GETA) at The Toledo Hospital.
After the patient has been successfully intubated at the beginning of the procedure, a trained nurse, using standard technique for placement of a oro/nasogastric tube, will place an appropriately sized NAVA catheter in the patient. The lumen of the NAVA tube can be used as a conventional oro/nasogastric tube and the electrodes will be connected to the Servo-I ventilator. Although the Servo-I is a ventilator, it will be used only as a monitor for this study. The position of the nasogastric tube will then be refined using the catheter positioning screen as needed.
During the course of the EPSA various arrhythmias may become evident. When these are noted, screen shots will be saved on the Servo-i monitor. Surface and electrogram recordings will be saved at the same time. The NAVA catheter will be disconnected from the Servo-I monitor during the ablation part of the procedure to prevent inadvertent damage to the monitor.
- Conditions
- Cardiac Arrhythmia
- Medical subject headings
- Arrhythmias, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Types of cardiac arrhythmia
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrhythmiaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProMedica Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Howard Stein, ProMedica Health System
- Investigators
- Howard Stein, MD, Principal investigator, Promedica Toledo CHildren's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040675
- Sponsor's protocol ID
- TCH01
- Status last verified
- Mar 2016
- First submitted
- 13 Jan 2014
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of NAVA-catheter Positioning Screen to Identify Different Cardiac Arrhythmias
- ClinicalTrials.gov ID
- NCT02040675
- Acronym / sponsor ID
- TCH01
- Conditions
- Cardiac Arrhythmia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- ProMedica Health SystemUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to validate a novel method of diagnosing arrhythmias using the NAVA catheter-positioning screen in patients who have a NAVA catheter in place.
Detailed description
The population will be a convenience sample of adults with various arrhythmias who are scheduled to undergo an electrophysiology study and-or ablation (EPSA) under general anesthesia (GETA) at The Toledo Hospital.
After the patient has been successfully intubated at the beginning of the procedure, a trained nurse, using standard technique for placement of a oro/nasogastric tube, will place an appropriately sized NAVA catheter in the patient. The lumen of the NAVA tube can be used as a conventional oro/nasogastric tube and the electrodes will be connected to the Servo-I ventilator. Although the Servo-I is a ventilator, it will be used only as a monitor for this study. The position of the nasogastric tube will then be refined using the catheter positioning screen as needed.
During the course of the EPSA various arrhythmias may become evident. When these are noted, screen shots will be saved on the Servo-i monitor. Surface and electrogram recordings will be saved at the same time. The NAVA catheter will be disconnected from the Servo-I monitor during the ablation part of the procedure to prevent inadvertent damage to the monitor.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population will be a convenience sample of adults with various arrhythmias who are scheduled to undergo an electrophysiology study and-or ablation (EPSA) under general anesthesia (GETA) at The Toledo Hospital.
Key inclusion criteria (1 listed)
- Cardiac arrhythmia
Key exclusion criteria (1 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Types of cardiac arrhythmia
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2016.
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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.
Howard Stein, MD principal investigator
Promedica Toledo CHildren's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrhythmia, run by ProMedica Health System 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 1 inclusion and 1 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 29 Mar 2016. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Types of cardiac arrhythmia (time frame: 1 year). 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 29 Mar 2016.