Late Function After Surgery for Transposition of the Great Arteries

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Brief Title

Late Function After Surgery for Transposition of the Great Arteries

Official Title

Late Function After Surgery for Transposition of the Great Arteries

Brief Summary

      The investigators proposed to review the exercise tolerance, cardiac function, and quality of
      life in patients born with transposition of the great arteries that have undergone surgery
      with either the Mustard or Senning procedure. Participants will complete a questionnaire. The
      investigators will review the participants' recent cardiac function testing which will assess
      their current health status. These tests include an echocardiogram, a metabolic exercise
      stress test, cardiac imaging, and a 24-hour Holter monitor. This collection of testing
      results will be compared specifically with previously acquired data during the first phases
      of this study (published in 2001 and 2007).
    

Detailed Description

      1. Enrolled subjects must consent to the study and authorize release of health information.
           All studies obtained as part of this research study are considered part of routine care.

        2. Prior to testing, subjects must complete a questionnaire assessing quality of life. This
           is the same questionnaire that has been used in the previous portions of this study.

        3. The investigators will review results of cardiac imaging for all participants consisting
           of a cardiac MRI or cardiac CT obtained within the last 5 years. If this data does not
           exist or is outdated, participants will have a new study.

        4. The investigators will review results of cardiac imaging for all participants consisting
           of an echocardiogram within the last 5 years. If this data does not exist or is
           outdated, participants will have a new study.

        5. The investigators will review results of cardiac function testing for all participants
           consisting of an exercise stress test obtained within the last 5 years. If this data
           does not exist or is outdated, participants will have a new study. End criteria for the
           exercise stress test includes either

           a. Achieving two or more of the following: i. Heart rate of > 95% of age-predicted
           maximum (using equation 220-age = maximal heart rate) ii. RER > 1.1 iii. VO2 plateau
           defined as The VO2 plateau was defined as a change in VO2 during the final minute of
           exercise less than 2 SD below the mean of increases between previous workloads iv. RPE >
           8 on OMNI RPE scale v. Volitional exertion OR b. Achievement of any of the
           contraindications to exercise testing.

        6. The investigators will review results of cardiac rhythm monitoring for all participants
           consisting of a 24 hour Holter monitor obtained within the last 5 years. If this data
           does not exist or is outdated, participants will have a new study.
    


Study Type

Observational


Primary Outcome

Survival

Secondary Outcome

 Quality of Life

Condition

Transposition of Great Vessels



Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

45

Start Date

March 3, 2017

Completion Date

June 30, 2018

Primary Completion Date

June 30, 2018

Eligibility Criteria

        Inclusion Criteria:

          1. Participants must have had an atrial switch procedure (Mustard or Senning operation).
             Since these operations were last performed on this population in the early 1980's all
             patients will be older than 18 years of age at the time of enrollment.

          2. Patients must be willing to adhere to the guidelines of this study

        Exclusion Criteria:

          1. Patients who are medically unstable

          2. Patients that are non-ambulatory

          3. Patients with a history of exercise induced arrhythmia

          4. Patients with atrial flutter or history of treatment resistant atrial flutter

          5. Patients who are pregnant.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03078413

Organization ID

1011003175


Responsible Party

Principal Investigator

Study Sponsor

Indiana University


Study Sponsor

, , 


Verification Date

November 2018