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Study identifier: NCT05809310 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Effects Branch PA Stenting d-TGA, ToF and TA

Condition: Transposition of Great Vessels · Tetralogy of Fallot · Truncus Arteriosus  ·  Sponsor: UMC Utrecht

PhaseNA
Planned participants56
Who can joinAll sexes, 8 Years to no upper limit
Healthy volunteersNo

About this study

The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The main question\[s\] it aims to answer are: The primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions. Participants will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht/WKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standa…

This description comes directly from the study's public registry record.

Talk to the study team

Hans Breur, MD, PhD  ·  +31 88 75 754 59  ·  h.breur@umcutrecht.nl

Renée Joosen, MSc  ·  r.s.joosen-2@umcutrecht.nl

Always discuss trial participation with your own doctor first.

Locations (4)

Amsterdam University Medical Center location AMCAmsterdam, NetherlandsNot Yet Recruiting
Leiden University Medical CenterLeiden, NetherlandsNot Yet Recruiting
Erasmus Medical CenterRotterdam, NetherlandsNot Yet Recruiting
UMC Utrecht/WKZUtrecht, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT05809310