Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Proper Extent of Maze Intercaval Lesion (Maze)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (Unable to obtain funding source)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

Tracking Information
First Submitted Date March 15, 2017
First Posted Date March 27, 2017
Last Update Posted Date May 30, 2018
Estimated Study Start Date April 15, 2018
Estimated Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 21, 2017)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03091205 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Proper Extent of Maze Intercaval Lesion
Official Title Proper Extent of Maze Intercaval Lesion
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients scheduled for any cardiac surgery where visualization and mapping of cavo-atrial junction is possible
Condition Atrial Fibrillation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: May 25, 2018)
0
Original Estimated Enrollment
 (submitted: March 21, 2017)
50
Estimated Study Completion Date April 15, 2019
Estimated Primary Completion Date April 15, 2019   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03091205
Other Study ID Numbers 017-048
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Baylor Research Institute
Study Sponsor Baylor Research Institute
Collaborators Not Provided
Investigators
Principal Investigator: Timothy George, M.D Baylor Reasearch Institute
PRS Account Baylor Research Institute
Verification Date May 2018