Atrial FibrillationMazeNCT03091205
Proper Extent of Maze Intercaval Lesion
An observational study of Atrial Fibrillation, run by Baylor Research Institute at 1 site in United States.
Trial summary
It's hypothesized that a mean and range distance from the cavo-atrial junction to the area where there is complete loss of conductive tissue can be measured to better inform surgeons performing the Cox-Maze procedure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2018to 15 Apr 2019
- 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: Patients scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible
Who may be able to join
- Age ≥ 18 years male or female
- Scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible
- Subjects willing and able to provide written informed consent
Who cannot join
- Subjects receiving surgery with non-sternotomy access
- Presence of or history of transvenous pacing leads
- Subjects receiving a re-do cardiac surgery
- Subjects with a history of pericarditis
- Subjects who are in atrial fibrillation or atrial flutter and cannot be converted out of it.
- Any medical condition or finding for which the Investigator used medical discretion to determine the subject should be excluded
- Subject is currently participating in another clinical trial.
- Subject is unable to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
It's hypothesized that a mean and range distance from the cavo-atrial junction to the area where there is complete loss of conductive tissue can be measured to better inform surgeons performing the Cox-Maze procedure. A patient scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible could be entered into the study if they meet the inclusion/exclusion requirements.
- Conditions
- Atrial Fibrillation
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance until complete loss of conductive tissue
To measure the mean and range distance from the cavo-atrial junction to the area where there is complete loss of conductive tissue.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start15 Apr 2018 (estimated)
- Primary completion15 Apr 2019 (estimated)
- Study completion15 Apr 2019 (estimated)
Why it stopped: Unable to obtain funding source
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy George, M.D, Principal investigator, Baylor Reasearch Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091205
- Sponsor's protocol ID
- 017-048
- Acronym
- Maze
- Status last verified
- May 2018
- First submitted
- 15 Mar 2017
- Last updated
- 30 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proper Extent of Maze Intercaval Lesion
- ClinicalTrials.gov ID
- NCT03091205
- Acronym / sponsor ID
- Maze / 017-048
- Conditions
- Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to obtain funding source
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 15 Apr 2018 (estimated)
- Primary completion
- 15 Apr 2019 (estimated)
- Study completion
- 15 Apr 2019 (estimated)
- First posted
- 27 Mar 2017 (actual)
- 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.
It's hypothesized that a mean and range distance from the cavo-atrial junction to the area where there is complete loss of conductive tissue can be measured to better inform surgeons performing the Cox-Maze procedure. A patient scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible could be entered into the study if they meet the inclusion/exclusion requirements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible
Key inclusion criteria (3 listed)
- Age ≥ 18 years male or female
- Scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible
- Subjects willing and able to provide written informed consent
Key exclusion criteria (8 listed)
- Subjects receiving surgery with non-sternotomy access
- Presence of or history of transvenous pacing leads
- Subjects receiving a re-do cardiac surgery
- Subjects with a history of pericarditis
- Subjects who are in atrial fibrillation or atrial flutter and cannot be converted out of it.
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
Distance until complete loss of conductive tissue
Time frame: 6 Months
To measure the mean and range distance from the cavo-atrial junction to the area where there is complete loss of conductive tissue.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
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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.
Timothy George, M.D principal investigator
Baylor Reasearch Institute
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 Atrial Fibrillation, run by Baylor Research Institute 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 8 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: withdrawn, as of the sponsor's last update on 30 May 2018. 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 was withdrawn before enrolling participants, so there are no results.
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?
Distance until complete loss of conductive tissue (time frame: 6 Months). 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 30 May 2018; AzTrials last refreshed its copy on 3 Nov 2026.