The effects of branch pulmonary artery stenting in d-TGA, ToF and TA: a randomized control trial

• Conditions: narrowed pulmonary artery; pulmonary artery stenosis; 10007510; 10003184; 10003216

• Registration Number: NL-OMON53404
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 56

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The difference in VO2 max as parameter for exercise capacity between the<br /><br>interventional and control group. </p><br>