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Proper Extent of Maze Intercaval Lesion

Proper Extent of Maze Intercaval Lesion

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03091205
Acronym
Maze
Enrollment
0
Registered
2017-03-27
Start date
2018-04-15
Completion date
2019-04-15
Last updated
2018-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Brief 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. 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.

Interventions

None listed

Sponsors

Baylor Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Distance until complete loss of conductive tissue6 MonthsTo measure the mean and range distance from the cavo-atrial junction to the area where there is complete loss of conductive tissue.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026