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Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation

RecruitingNAAges 12 Years - anyAllCopenhagen University Hospital, Rigshospitalet
NCT04084132 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Tetralogy of Fallot (ToF) is a congenital heart defect with four major features including right ventricular outflow tract obstruction. About 25 children are born with this condition in Denmark every year. Corrective surgery is usually performed within the first year. In 50 % of patients, enlargement with a patch is necessary to achieve relief of the outflow tract obstruction. This however results in severe pulmonary regurgitation, which eventually leads to volume overload, right ventricular dysfunction and arrhythmia. To avoid these late complications, pulmonary valve replacement with a prosthesis if performed when patients meet the current guideline criteria. Most patients meet the guideline criteria for revalving when they are between 20 and 30 years of age. The current guidelines however, are based solely on retrospective studies and novel research reveals that in more than 50 % of pa

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📋 Eligibility rules (as published)
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.
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What it tests

  • Pulmonary valve replacement
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Where

3 sites
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Odense University Hospital
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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