Effects Branch PA Stenting d-TGA, ToF and TA

Launched by UMC UTRECHT · Mar 29, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a special procedure called percutaneous intervention on patients with certain heart conditions, specifically those with Transposition of Great Vessels (d-TGA), Tetralogy of Fallot (ToF), or Truncus Arteriosus (TA). The aim is to see how this procedure can improve exercise capacity, which is how well patients can perform physical activities. The trial also looks at how this intervention affects the function of the right side of the heart, as well as identifying early signs that could help doctors decide when to perform these interventions.

To participate in this study, patients must be at least 8 years old and have been diagnosed with one of the specified heart conditions. They will undergo several tests at the start and about six months later to monitor their heart health and exercise ability. Participants will either receive the percutaneous intervention or continue with standard care without the procedure. Throughout the study, researchers will gather information to help understand the long-term effects of the intervention and improve patient care for those with these heart conditions.

Gender

ALL

Eligibility criteria

• 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)