HP 4.2 Early re-intervention in infants after corrective surgery for Tetralogy of Fallot (completed)

Multi-centric, prospective, open, non-randomised

90 patients

Duration of study: July 2007 – August 2012
End date for recruitment: November 2010

• How efficient are surgical (e.g. pulmonary valve replacement) and/or catheter interventions (e.g. stents in the case of pulmonary arterial stenosis) to treat residual lesions of the pulmonary valve or the pulmonary arteries in very young children after corrective surgery for Tetralogy of Fallot, in relation to quantified findings on right ventricular function obtained by means of MRI?

• What value can be assigned to ventricular function parameters in these patients obtained by myocardial tissue Doppler imaging, relative to the quantitative findings on right ventricular function found using MRI (validation of tissue Doppler imaging results)?
• Which set of ventricular function parameters (MRI, tissue Doppler) offers the most reliable results in terms of establishing a prognosis for recovery of right ventricular function (as determined by an MRI quantification scan) after re-intervention? Is it possible to determine the optimum timing on the basis of these data?
• Can any other statement be made concerning the optimum time for re-intervention by analysing matched subgroups (based on anatomy at birth, corrective procedure, time elapsed since correction, present haemodynamics) receiving different forms of treatment prescribed according to local criteria in each separate centre (as opposed to a centrally co-ordinated approach)?

• Tetralogy of Fallot, including pulmonary atresia with VSD as its extreme form
• Patients under 8 years of age having undergone corrective surgery for Tetralogy of Fallot, where catheterisation or re-intervention has become necessary to treat residual defects of haemodynamic relevance (judged according to conventional criteria).

• DORV (without subaortic VSD)
• Associated severe heart defect (e.g. atrioventricular canal)
• Absolute contraindication of MRI, for such reasons as the presence of a heart pacemaker, implanted neurostimulators or other magnetisable foreign object
• Presence of other clinically relevant diseases such as malignant neoplasm or florid diseases (unless judged acceptable by the principal investigator)

2 consultations

€2,000 per patient

A number of clinics and heart centres all over Germany are taking part in the study. An up-to-date list of these participants can be found here …