NCT03078413|Completed
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Sponsor study identifier
observational
45
1 country
1
Study Start
March 3, 2017
Actual (reported)Primary Completion
June 30, 2018
Actual (reported)Study Completion
June 30, 2018
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2018
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2, 2017
Actual (reported)March 3, 2017
Actual (reported)March 13, 2017
Actual (reported)June 30, 2018
Actual (reported)June 30, 2018
Actual (reported)Survival
Survival following Mustard procedure to time of study
2 years
Quality of Life
2 years
Exercise Capacity
2 years
Cardiac Function
2 years
Cardiac rhythm assessment
2 years
Participants must have had an atrial switch procedure (Mustard or Senning operation) and have participated in the prior two installments of this study.
Indiana University Health
Indianapolis, Indiana, 46202, United States
Martins P, Castela E. Transposition of the great arteries. Orphanet J Rare Dis. 2008 Oct 13;3:27. doi: 10.1186/1750-1172-3-27.
Moons P, Gewillig M, Sluysmans T, Verhaaren H, Viart P, Massin M, Suys B, Budts W, Pasquet A, De Wolf D, Vliers A. Long term outcome up to 30 years after the Mustard or Senning operation: a nationwide multicentre study in Belgium. Heart. 2004 Mar;90(3):307-13. doi: 10.1136/hrt.2002.007138.
45 participants (actual enrollment reported by the registry).
First Submitted
March 2, 2017
First Posted
March 13, 2017
Study Start
March 3, 2017
Actual (reported)Comprehensive Long-term Follow up of Adults With Arterial Switch Operation
Contact the study team to confirm eligibility.
Warnes CA. Transposition of the great arteries. Circulation. 2006 Dec 12;114(24):2699-709. doi: 10.1161/CIRCULATIONAHA.105.592352.
Dos L, Teruel L, Ferreira IJ, Rodriguez-Larrea J, Miro L, Girona J, Albert DC, Goncalves A, Murtra M, Casaldaliga J. Late outcome of Senning and Mustard procedures for correction of transposition of the great arteries. Heart. 2005 May;91(5):652-6. doi: 10.1136/hrt.2003.029769.
Ebenroth ES, Hurwitz RA. Functional outcome of patients operated for d-transposition of the great arteries with the Mustard procedure. Am J Cardiol. 2002 Feb 1;89(3):353-6. doi: 10.1016/s0002-9149(01)02242-1. No abstract available.
Primary Completion
June 30, 2018
Actual (reported)Study Completion
June 30, 2018
Actual (reported)Last Updated
November 19, 2018
Record last verified: 2018-11
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Source: ClinicalTrials.gov.
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