Status:
RECRUITING
Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Aarhus University Hospital
Odense University Hospital
Conditions:
Tetralogy of Fallot
Pulmonary Regurgitation
Eligibility:
All Genders
12+ years
Phase:
NA
Brief Summary
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 y...
Eligibility Criteria
Inclusion
- ToF with pulmonary stenosis repaired with a TAP within the first two years of life.
- RVOT anatomy is suitable for implantation of an adult sized conduit ( 18 mm homograft or Contegra graft) as assessed by MRI.
Exclusion
- ToF with pulmonary atresia, ToF with common atrioventricular canal, ToF with absent pulmonary valve syndrome, major aortopulmonary collateral arteries and other significant associated anomalies.
- Palliation with a shunt (Blalock-Taussig or central) at any time.
- The patient is symptomatic.
- Sustained supraventricular or ventricular arrhythmia.
- RVEDVi \> 140 mL/m2 as assessed by MRI (appendix 1).
- RVESVi \> 60 mL/m2 as assessed by MRI.
- RVEF \< 50 % as assessed by MRI.
- Moderate or severe tricuspid regurgitation as assessed by echocardiography or MRI.
- Significant residual lesions requiring intervention (e.g. ventricular septal defect, aortic regurgitation, branch pulmonary artery stenosis).
- Co-morbidity preventing exercise testing (e.g. genetics, neuro-cognitive dysfunction, physical disability).
- Contraindication for MRI (e.g. permanent pacemaker, intra-cardiac defibrillator, intracranial ferro-magnetic device).
- Pregnancy at time of inclusion.
- Age \< 12 or unable to comply with instructions given during MRI or exercise testing.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2031
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04084132
Start Date
April 1 2019
End Date
December 31 2031
Last Update
September 10 2019
Active Locations (3)
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1
Aarhus University Hospital
Aarhus, Denmark, 8200
2
Rigshospitalet
Copenhagen, Denmark, 2100
3
Odense University Hospital
Odense, Denmark, 5000