NL-OMON53404Not yet recruitingNot Applicable
The effects of branch pulmonary artery stenting in d-TGA, ToF and TA: a randomized control trial - Effects branch PA stenting d-TGA, ToF and TA
niversitair Medisch Centrum Utrecht0 sites56 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 56
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 2 to 64 (—)
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 <=55% (Van der Ven et al. EHJ Cardiovasc Imaging 2020)
- •o >=18 years RVEF<50% (Maceira et al. Eur Heart J 2006)
- •Progressive tricuspid regurgitation (TR) (>=moderate)
- •Bifurcation stenosis
- •o Significant unilateral stenosis (>=50%)
- •o 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)
- •o <18 years (Takken et al. Ann Am Thorac Soc 2017) VO2 peak <35 mL·kg-
- •1·min-1 (boys)
- •VO2 peak <30 mL·kg-1·min-1 (girls)
- •o >=18 years (Kaminsky et al. Mayo Clin Proc 2015) VO2 peak <27 mL·kg-
- •1·min-1 (men) VO2 peak <19 mL·kg-1·min-1 (women)
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)
Investigators
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