Effects of stenting on exercise capacity in patients with certain congenital heart defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the impact of percutaneous interventions for branch pulmonary artery stenosis on exercise capacity in patients with dextro transposition of the great arteries (d-TGA), Tetralogy of Fallot (ToF), and Truncus Arteriosus (TA). Participants will undergo a series of examinations, including echocardiograms and cardiopulmonary exercise testing, at baseline and approximately six months later. The study also seeks to assess right ventricular function and identify early markers for improving the timing of these interventions. It is a multicenter randomized controlled trial conducted across several Dutch interventional centers.

Why it matters

Who can join: the full rules

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

Exclusion Criteria:

One or more of the following inclusion criteria:

* All class IIa indications for a branch PA intervention:
* Persistent decreased RV function (based on gold standard CMR)

  * \<18 years RVEF ≤55% (28)
  * ≥18 years RVEF\<50% (29)
* 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
* 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)

Where it's running

• UMC Utrecht/WKZ
  Utrecht, Netherlands Recruiting
• Amsterdam University Medical Center location AMC
  Amsterdam, Netherlands Not yet recruiting
• Leiden University Medical Center
  Leiden, Netherlands Not yet recruiting
• Erasmus Medical Center
  Rotterdam, Netherlands Not yet recruiting

Study contacts

• Study coordinator: Hans Breur, MD, PhD
• Email: h.breur@umcutrecht.nl
• Phone: +31 88 75 754 59

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Registry of patients with Tetralogy of Fallot using implantable defibrillators

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.