Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorRigshospitalet, Denmark
About this trial
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 patients who are treated according to current practice, right ventricular volumes and function as well as exercise capacity and burden of arrhythmia do not normalize or improve. 500 patients with ToF will be enrolled in a multicentre, cross-sectional study, which will yield information about the long-term outcomes after initial repair of ToF, as well as suggestions about the optimal timing for re-valving. Among patients included in the cross-sectional study, 120 patients with free pulmonary regurgitation, will be randomized evenly for early or later re-valving with at least 10-years of follow-up, for evaluation of long-term efficacy and safety of early re-valving.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Pulmonary valve replacement
Procedure/SurgerySurgical implantation of an adult-sized (≥ 18 mm) homograft or Contegra graft as right ventricle-to-pulmonary artery conduit under cardiopulmonary bypass through a sternotomy.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Early re-valvingExperimental treatment 1 intervention
Group B: Later re-valvingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean right ventricular end-diastolic volume indexed to body surface area
Right ventricular end-diastolic volume (mL) indexed by body surface area (m2) will be assessed in both the early re-valving group and later re-valving group for calculation of the mean in each group and analysis of statistical significance of the difference will be performed. Higher right ventricular end-diastolic volumes are considered a worse outcome.
Time frame
3 years after randomization2
Rate of deceased patients (all-cause mortality) and total number of patients
The rate of deceased patients (irrespective of the cause of death) and total number of patients will be calculated for both the early and later re-valving group and analysis of statistical significance of the difference between the groups will be performed.
Time frame
3 years after randomizationSecondary outcomes
1
Right ventricular end-systolic volume indexed to body surface area
Right ventricular end-systolic volume (mL) indexed by body surface area (m2) will be assessed in both the early re-valving group and later re-valving group for calculation of the mean in each group and analysis of statistical significance of the difference will be performed. Higher right ventricular end-systolic volumes are considered a worse outcome.
Time frame
Assessed once every year for 10 years after randomization2
Right ventricular ejection fraction
Right ventricular ejection fraction (%) will be assessed in both the early re-valving group and later re-valving group for calculation of the mean in each group and analysis of statistical significance of the difference will be performed. Lower right ventricular ejection fraction are considered a worse outcome.
Time frame
Assessed once every year for 10 years after randomization3
Left ventricular end-diastolic volume indexed to body surface area
Left ventricular end-diastolic volume (mL) indexed by body surface area (m2) will be assessed in both the early re-valving group and later re-valving group for calculation of the mean in each group and analysis of statistical significance of the difference will be performed. Higher left ventricular end-diastolic volumes are considered a worse outcome.
Time frame
Assessed once every year for 10 years after randomization4
Left ventricular end-systolic volume indexed to body surface area
Left ventricular end-diastolic volume (mL) indexed by body surface area (m2) will be assessed in both the early re-valving group and later re-valving group for calculation of the mean in each group and analysis of statistical significance of the difference will be performed. Higher left ventricular end-systolic volumes are considered a worse outcome.
Time frame
Assessed once every year for 10 years after randomizationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Rigshospitalet, Denmark
Lead sponsor
Aarhus University Hospital
Collaborator
Odense University Hospital
Collaborator
Source ClinicalTrials.gov