Effects Branch PA Stenting d-TGA, ToF and TA
Transposition of Great Vessels, Tetralogy of Fallot, Truncus Arteriosus
About this trial
This is an interventional treatment trial for Transposition of Great Vessels focused on measuring Exercise capacity
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)
Sites / Locations
- Amsterdam University Medical Center location AMC
- Leiden University Medical Center
- Erasmus Medical Center
- UMC Utrecht/WKZRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Interventional group
Control group
Percutaneous intervention for PA stenosis
Conservative management (percutaneous intervention for PA stenosis 6 months postponed)