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Compares treatment options for Tetralogy of Fallot
Official title Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation
ClinicalTrials.gov ID: NCT04084132
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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.
You likely can't join if
- ToF with pulmonary atresia, ToF with common atrioventricular canal, ToF with absent pulmonary valve syndrome, major aortopulmonary collateral...
- 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.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus, Denmark
- Copenhagen, Denmark
- Odense, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus, Denmark; Copenhagen, Denmark; Odense, Denmark. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.