Proper Extent of Maze Intercaval Lesion (Maze)
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ClinicalTrials.gov Identifier: NCT03091205 |
Recruitment Status :
Withdrawn
(Unable to obtain funding source)
First Posted : March 27, 2017
Last Update Posted : May 30, 2018
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Condition or disease |
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Atrial Fibrillation |
Study Type : | Observational |
Actual Enrollment : | 0 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Proper Extent of Maze Intercaval Lesion |
Estimated Study Start Date : | April 15, 2018 |
Estimated Primary Completion Date : | April 15, 2019 |
Estimated Study Completion Date : | April 15, 2019 |

- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091205
United States, Texas | |
The Heart Hospital Baylor Plano | |
Plano, Texas, United States, 75093 |
Principal Investigator: | Timothy George, M.D | Baylor Reasearch Institute |
Responsible Party: | Baylor Research Institute |
ClinicalTrials.gov Identifier: | NCT03091205 History of Changes |
Other Study ID Numbers: |
017-048 |
First Posted: | March 27, 2017 Key Record Dates |
Last Update Posted: | May 30, 2018 |
Last Verified: | May 2018 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes |