Comparing early and late pulmonary valve replacement in children with Tetralogy of Fallot

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 investigates the timing of pulmonary valve replacement in children diagnosed with Tetralogy of Fallot who experience free pulmonary regurgitation. The study aims to determine whether early intervention leads to better outcomes compared to later re-valving, as current guidelines are based on retrospective data. Participants will undergo MRI assessments to evaluate their right ventricular anatomy and function, which will guide the timing of the valve replacement procedure. The trial seeks to improve long-term heart function and reduce complications associated with pulmonary regurgitation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. ToF with pulmonary stenosis repaired with a TAP within the first two years of life.
2. RVOT anatomy is suitable for implantation of an adult sized conduit ( 18 mm homograft or Contegra graft) as assessed by MRI.

Exclusion Criteria:

1. ToF with pulmonary atresia, ToF with common atrioventricular canal, ToF with absent pulmonary valve syndrome, major aortopulmonary collateral arteries and other significant associated anomalies.
2. Palliation with a shunt (Blalock-Taussig or central) at any time.
3. The patient is symptomatic.
4. Sustained supraventricular or ventricular arrhythmia.
5. RVEDVi \> 140 mL/m2 as assessed by MRI (appendix 1).
6. RVESVi \> 60 mL/m2 as assessed by MRI.
7. RVEF \< 50 % as assessed by MRI.
8. Moderate or severe tricuspid regurgitation as assessed by echocardiography or MRI.
9. Significant residual lesions requiring intervention (e.g. ventricular septal defect, aortic regurgitation, branch pulmonary artery stenosis).
10. Co-morbidity preventing exercise testing (e.g. genetics, neuro-cognitive dysfunction, physical disability).
11. Contraindication for MRI (e.g. permanent pacemaker, intra-cardiac defibrillator, intracranial ferro-magnetic device).
12. Pregnancy at time of inclusion.
13. Age \< 12 or unable to comply with instructions given during MRI or exercise testing.

Where it's running

• Rigshospitalet
  Copenhagen, Denmark Recruiting
• Aarhus University Hospital
  Aarhus, Denmark Not yet recruiting
• Odense University Hospital
  Odense, Denmark Not yet recruiting

Study contacts

• Principal investigator: Lars Søndergaard, MD, DMSc — Copenhagen University Hospital, Rigshospitalet
• Study coordinator: Mathis Gröning, MD, DMSc
• Email: mathis.groening@regionh.dk
• Phone: +45 42404489

Similar studies

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

• High intensity interval training for patients with congenital heart defects

  This study is testing if a 12-week home workout program can help young people with certain heart defects exercise better and feel stronger.

  Recruiting Erasmus Medical Center · Nijmegen, Gelderland and 1 other locations · NCT06771687

• Using Dapagliflozin to Improve Heart and Lung Function in Patients with Repaired Tetralogy of Fallot

  This study is testing if the medication Dapagliflozin can help improve heart and lung function in adults who have had surgery for Tetralogy of Fallot.

  Recruiting Phase 4 The University of Hong Kong · Hong Kong · NCT06668389

• Evaluation of the VenusP-Valve for treating pulmonary regurgitation

  This study is testing a new valve to see if it can safely help people with severe pulmonary regurgitation feel better after a heart procedure.

  Recruiting Venus MedTech (HangZhou) Inc. · Irvine, California · NCT06010563

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

  This study is testing if a procedure to open blocked arteries can help people with certain heart defects, like d-TGA, ToF, and TA, exercise better.

  Recruiting UMC Utrecht · Amsterdam and 3 other locations · NCT05809310

• Registry for patients with repaired Tetralogy of Fallot

  This study is collecting information from patients who have had surgery for Tetralogy of Fallot to see how their hearts are doing over time using special imaging tests.

  Recruiting Azienda Ospedaliero, Universitaria Ospedali Riuniti · Ancona, The Marches · NCT05288894

• How transcatheter pulmonary valves interact with electrical pathways in repaired Tetralogy of Fallot

  This project will test if detailed right-ventricular electrical mapping before transcatheter pulmonary valve replacement can find conduction isthmuses that might be 'jailed' and linked to ventricular tachycardia in people with repaired Tetralogy of Fallot.

  Recruiting Boston Children's Hospital · Boston, Massachusetts · NCT05236153

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.