Study on the Effects of Pulmonary Artery Stenting in Patients with d-TGA, Tetralogy of Fallot, and Truncus Arteriosus

What this Trial Is About

Researchers are studying the effects of percutaneous interventions for branch pulmonary artery PA stenosis on exercise capacity in patients with dextro transposition of the great arteries d-TGA, Tetralogy of Fallot ToF, and Truncus Arteriosus TA. This randomized controlled trial also aims to assess the impact of these interventions on right ventricular RV function and to identify early markers to improve the timing of treatment. The study responds to the need for clearer guidelines on when to perform these interventions, as current knowledge about their effects on exercise capacity and heart function is limited. Participants are divided into two groups one undergoing percutaneous stent placement for PA stenosis and a control group receiving conservative management with potential delayed intervention. Both groups will receive standard care evaluations, including transthoracic echocardiogram TTE, cardiopulmonary exercise testing CPET, and cardiac magnetic resonance imaging CMR. The interventional group will have additional low dose dobutamine stress MRI at certain centers and RV pressure measurements during the intervention. Quality of life questionnaires will be collected at baseline and shortly after intervention or corresponding time points in controls. Long-term follow-up with TTE, CPET, and CMR will occur within 2 to 4 years. During the study, participants will undergo examinations at baseline and approximately six months later to measure exercise capacity VO2 max, RV function, and adaptation. Assessments include imaging, exercise testing, and questionnaires to evaluate heart performance and quality of life. Researchers will compare results between groups to determine the effects of the intervention. Safety and technical success will also be monitored through pressure and gradient measurements. The total study duration includes initial assessments, intervention or observation periods, and extended follow-up to understand long-term outcomes.

Effects Branch PA Stenting d-TGA, ToF and TA