narrowed pulmonary artery pulmonary artery stenosis
Conditions
Interventions
During this trial, the intervention group will undergo a percutaneous
intervention for branch PA stenosis. This is a standard treatment for branch PA
stenosis according to international guidelines.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
2 Years to 64 Years
Inclusion 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 And one or more of the following inclusion criteria (Baumgartner et al. Eur Heart J 2021; Feltes et al. Circulation 2011; Tatewaki et al. Gen Thorac Cardiovasc Surg 2018): • All class IIa indications for a branch PA intervention: • Persistent decreased RV function (based on gold standard CMR) o =18 years RVEF=moderate) • Bifurcation stenosis o Significant unilateral stenosis (>=50%) o Borderline bilateral PA stenosis (40-70%) • Unbalanced perfusion ( 2/3 based on echocardiography • Reduced lung perfusion or decreased objective exercise capacity (based of gold standard VO2 max during CPET) o =18 years (Kaminsky et al. Mayo Clin Proc 2015) VO2 peak
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • All class I indications for a branch PA stenosis intervention: o Doppler peak gradient >64 mmHg o Symptoms related to branch PA stenosis o R-L shunt via ASD or VSD o Recently developed decreased RV function • Physical or mental contraindications for at least one of the examinations (e.g. exercise test, MRI, QoL questionnaire)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in VO2 max as parameter for exercise capacity between the interventional and control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Technical success • Complications during the intervention • Complications after the intervention • Parameters for exercise capacity o Peak workload (W and % predicted) o O2 pulse (ml and % predicted) o VE/VCO2 slope • Parameters for RV systolic function o RVEF (%), measured via CMR o RV strain (%), measured via speckle tracking echocardiography and CMR feature tracking o RV fractional area change (FAC) (%) o RV pressure on echocardiography (TI gradient) • Parameters for RV contractility o RV end systolic elastance (Ees) measured via pressure volume loops o RV ESV (ml/m2) measured via dobutamine stress CMR o RVEF (%) measured via dobutamine stress CMR • Parameters for RV remodeling • Parameters for RV-PA coupling (invasive in intervention group) • Lung perfusion (%) measured via MRI o Left lung perfusion o Right lung perfusion • Quality of life | — |
Countries
Netherlands
Outcome results
None listed