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Stenting narrowed lung arteries in people with certain congenital heart conditions

Tests stenting narrowed lung artery branches on exercise capacity in congenital heart disease.

Key facts

Who runs it
UMC Utrecht
Where
Netherlands4 sites in 1 countryChoose a country to see its sites
Trial code
Registry title
Effects Branch PA Stenting d-TGA, ToF and TA
Status
Recruiting
People taking part
56 people, planned
Started
18 Apr 2023
Expected to end
31 Dec 2027
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Percutaneous intervention (stent) for PA stenosis
Record updated
30 March 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with d-TGA after arterial switch surgery (ASO), Tetralogy of Fallot (ToF) or Truncus Arteriosus (TA). It studies stenting of a narrowed lung artery branch (PA stenosis).

Age
8 years and older.
Sex
All sexes.
Disease stage
d-TGA after arterial switch operation (ASO), ToF or TA. The summary describes patients with a class II reason for a lung artery branch treatment.
Earlier treatment
People with d-TGA must have had an arterial switch operation (ASO).

Main reasons for not taking part

  • The record lists class IIa reasons for a lung artery branch treatment under its exclusion criteria.
  • Weak right heart pumping on heart MRI: RVEF ≤55% under 18 years, RVEF<50% at 18 years or older.
  • Worsening leak of the tricuspid heart valve, moderate or worse.
  • Narrowing at the lung artery split, uneven lung blood flow (≤35/65%), or RV/LV pressure ratio > 2/3.
  • Low exercise capacity on exercise test, for example VO2 peak <27 mL∙kg-1∙min-1 in men aged 18 or older.

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Persistent decreased RV function (based on gold standard CMR); <18 years RVEF ≤55% (28); ≥18 years RVEF<50% (29)
  • 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)
  • One or more of the following inclusion criteria:
  • All class IIa indications for a branch PA intervention:
  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

The goal of this randomized controlled trial is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA.

Read full original descriptionShow less

The main question[s] it aims to answer are:

The primary study objective is to identify the effects of percutaneous interventions for branch PA stenosis on exercise capacity in patients with d-TGA, ToF and TA. The secondary objectives are 1) to assess the effects of percutaneous interventions for branch PA stenosis on RV function and 2) to define early markers for RV function and adaptation to improve timing of these interventions.

Participants will undergo the same series of examinations at baseline and approximately 6 months follow-up (within 6 week time-range) as part of standard care: conventional transthoracic echocardiogram (TTE), cardiopulmonary exercise testing (CPET) and conventional Cardiac Magnetic Resonance (CMR) including a low dose dobutamine stress MRI to assess RV functional reserve. The low dose dobutamine stress MRI will be performed in the interventional group from the UMC Utrecht/WKZ and Erasmus MC because the LUMC and AUMC do not have a suitable infrastructure for the low dose dobutamine stress MRI and this cannot be achieved throughout the duration of this study. The baseline CMR in the interventional group will be performed as close as possible prior to the intervention but maximal 4 weeks prior to the intervention. In addition, the intervention group will undergo standard RV pressure measurements during the intervention. Quality of life (QoL) questionnaires will be obtained at baseline and 2 weeks post intervention (intervention group) or a similar time range in the control group, which is based on experts opinion. TTE, CPET and conventional CMR will be performed within 2-4 years follow-up to assess the long-term effects of percutaneous PA interventions.

Researchers will compare the difference in VO2 max (% predicted) between the interventional group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo a percutaneous intervention for a PA stenosis) and the control group (TGA, ToF or TA patients with a class II indication for a PA intervention who will undergo conservative management)

The 2 groups in the trial

  • Interventional groupTreatment being tested

    Percutaneous intervention for PA stenosis

    Treatment: Percutaneous intervention (stent) for PA stenosis

  • Control groupNo study treatment, for comparison

    Conservative management (percutaneous intervention for PA stenosis 6 months postponed)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Effects of Branch Pulmonary Artery Stenting in d-TGA, ToF and TA: a Randomized Control Trial
Plain-language title
Stenting narrowed lung arteries in people with certain congenital heart conditionsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
30 March 2025