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Late Function After Surgery for Transposition of the Great Arteries

Late Function After Surgery for Transposition of the Great Arteries

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03078413
Enrollment
45
Registered
2017-03-13
Start date
2017-03-03
Completion date
2018-06-30
Last updated
2018-11-19

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

Conditions

Transposition of Great Vessels

Keywords

Mustard Procedure

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 If this data does not exist or is outdated, participants will have a new study. 4.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 If this data does not exist or is outdated, participants will have a new study. 5.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 If this data does not exist or is outdated, participants will have a new study.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.

Interventions

None listed

Sponsors

Indiana University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

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

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.

Design outcomes

Primary

MeasureTime frameDescription
Survival2 yearsSurvival following Mustard procedure to time of study

Secondary

MeasureTime frameDescription
Quality of Life2 yearsQOL as assessed by questionnaire
Exercise Capacity2 yearsPeak oxygen consumption in mL/kg/min
Cardiac Function2 yearsRV ejection fraction (%) as measured by echocardiogram and MRI/CT
Cardiac rhythm assessment2 yearsPercentage of abnormal rhythm

Countries

United States

Outcome results

None listed

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