Actively Recruiting
Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation - Combined Cross-sectional and Prospective, Multi-centre, Randomized, Parallel-group Clinical Trial
Led by Rigshospitalet, Denmark · Updated on 2019-09-10
120
Participants Needed
3
Research Sites
365 weeks
Total Duration
On this page
Sponsors
R
Rigshospitalet, Denmark
Lead Sponsor
A
Aarhus University Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Tetralogy of Fallot (ToF) is a congenital heart defect characterized by four major features, including obstruction of the right ventricular outflow tract. About 25 children in Denmark are born with ToF each year, and corrective surgery is typically done within the first year of life. Many patients require enlargement of the outflow tract with a patch, which can lead to severe pulmonary regurgitation and later complications like right ventricular dysfunction and arrhythmias. This trial aims to evaluate the long-term outcomes after initial ToF repair and to determine the best timing for pulmonary valve replacement in patients with free pulmonary regurgitation. The study will enroll 500 patients in a multicenter, cross-sectional evaluation, with 120 patients who have free pulmonary regurgitation randomized into two groups. One group will undergo early pulmonary valve replacement within 3 months after randomization, while the other will have the procedure later when they meet current European guideline criteria. The valve replacement involves surgical implantation of an adult-sized homograft or Contegra graft under cardiopulmonary bypass through a sternotomy. Participants will be followed for at least 10 years to assess long-term safety and effectiveness. Participants will be monitored regularly with yearly assessments including heart function measurements by MRI, exercise testing, arrhythmia monitoring, quality of life evaluations, and health system contacts. Primary outcomes include right ventricular end-diastolic volume indexed to body surface area and mortality rates measured 3 years after randomization. Secondary outcomes cover additional cardiac function parameters, complication rates after surgery, stroke and mortality rates, and quality of life changes over 10 years. The study also tracks valve deterioration and other clinical events to gain comprehensive information on the impact of early versus later re-valving.
CONDITIONS
Brief Title
Early Versus Later Re-valving in Tetralogy of Fallot With Free Pulmonary Regurgitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Tetralogy of Fallot with pulmonary stenosis repaired with a transannular patch within the first two years of life
- Right ventricular outflow tract anatomy suitable for an adult-sized conduit (18 mm homograft or Contegra graft) as assessed by MRI
- Aged 12 years or older
- Able to comply with instructions during MRI and exercise testing
You will not qualify if you...
- Tetralogy of Fallot with pulmonary atresia, common atrioventricular canal, absent pulmonary valve syndrome, major aortopulmonary collateral arteries, or other significant anomalies
- Previous palliation with a shunt such as Blalock-Taussig or central shunt
- Currently symptomatic from heart condition
- Sustained supraventricular or ventricular arrhythmia
- Right ventricular end-diastolic volume indexed (RVEDVi) over 140 mL/m2 by MRI
- Right ventricular end-systolic volume indexed (RVESVi) over 60 mL/m2 by MRI
- Right ventricular ejection fraction (RVEF) below 50% by MRI
- Moderate or severe tricuspid valve regurgitation by echocardiography or MRI
- Significant residual heart lesions needing intervention (e.g., ventricular septal defect, aortic regurgitation, branch pulmonary artery stenosis)
- Co-morbidities preventing exercise testing such as genetic conditions, neuro-cognitive dysfunction, or physical disabilities
- Contraindications for MRI, including permanent pacemaker, intracardiac defibrillator, or intracranial ferromagnetic device
- Pregnancy at time of inclusion
- Under 12 years old or unable to follow instructions during MRI or exercise testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for assessments including MRI and exercise testing
Duration - Varies by participant; early re-valving within 3 months from randomization, later re-valving timed per clinical guidelines
Participants undergo pulmonary valve replacement either early within 3 months from randomization or later when guideline criteria are met.
1 surgical procedure visit and approximately 1 month of post-operative recovery monitoring
Duration - Up to 10 years
Participants are followed for up to 10 years with yearly assessments to monitor heart function, quality of life, and any complications.
Annual visits for assessments including MRI and exercise testing
Trial Site Locations
Total: 3 locations
1
Aarhus University Hospital
Aarhus, Denmark, 8200
Not Yet Recruiting
2
Rigshospitalet
Copenhagen, Denmark, 2100
Actively Recruiting
3
Odense University Hospital
Odense, Denmark, 5000
Not Yet Recruiting
Research Team
M
Mathis Gröning, MD, DMSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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