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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Recruitment Status : Withdrawn (Unable to obtain funding source)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
Sponsor:
Information provided by (Responsible Party):
Baylor Research Institute

Study Description
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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.

Condition or disease
Atrial Fibrillation

Study Design
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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

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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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
Study Population
Patients scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible
Criteria

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.
Contacts and Locations
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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


Locations
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United States, Texas
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
Sponsors and Collaborators
Baylor Research Institute
Investigators
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Principal Investigator: Timothy George, M.D Baylor Reasearch Institute
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes