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Effects Branch PA Stenting d-TGA, ToF and TA

RecruitingNAAges 8 Years - anyAllUMC Utrecht
NCT05809310 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 Magn

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📋 Eligibility rules (as published)
Inclusion Criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: * Patients with d-TGA post ASO, ToF or TA * ≥8 years Exclusion Criteria: One or more of the following inclusion criteria: * All class IIa indications for a branch PA intervention: * Persistent decreased RV function (based on gold standard CMR) * \<18 years RVEF ≤55% (28) * ≥18 years RVEF\<50% (29) * Progressive tricuspid regurgitation (TR) (≥moderate) * Isolated bifurcation stenosis: * Significant unilateral stenosis (≥50%) * Borderline bilateral PA stenosis (40-70%) * Unbalanced perfusion (≤35/65%) * RV/LV pressure ratio \> 2/3 based on echocardiography * Reduced lung perfusion or decreased objective exercise capacity (based of gold standard VO2 max during CPET) * \<18 years VO2 peak \<35 mL∙kg-1∙min-1 (boys) VO2 peak \<30 mL∙kg-1∙min-1 (girls) (30) * ≥18 years VO2 peak \<27 mL∙kg-1∙min-1 (men) VO2 peak \<19 mL∙kg-1∙min-1 (women) (31)
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What it tests

  • Percutaneous intervention (stent) for PA stenosis
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Where

4 sites
Amsterdam University Medical Center location AMC
Amsterdam, Netherlands
Leiden University Medical Center
Leiden, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands
UMC Utrecht/WKZ
Utrecht, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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