Clin2
NCT04084132Possibly a fitRecruiting

Testing earlier vs later valve replacement after repaired Tetralogy

Tetralogy of FallotPulmonary Regurgitation

Part of Genetic & congenital, Heart & circulation clinical trials.

This study compares doing a valve replacement earlier versus later in people born with Tetralogy of Fallot who already had heart surgery as babies. It may help decide the safest timing to protect heart function, especially right-sided pumping and valve leakage.

Summary written for real people, not researchers, by Clin2.

Phase
N/A
Enrollment
120 people
Ages
12 years and older
Study type
Interventional

Who can take part

  • You were born with Tetralogy of Fallot and had pulmonary valve repair using a TAP within the first 2 years of life
  • Your MRI shows the right area is large enough for an adult-sized replacement valve/conduit (about 18 mm)
  • You have no major other heart problems that would need extra procedures right away (like important remaining leaks or narrowed lung arteries)
  • You are not pregnant and can follow the study instructions, including MRI and exercise testing
  • Your MRI/heart scans show the right heart size and pumping are within limits (not too enlarged or weak) and tricuspid valve leak is not moderate/severe
  • You can safely have MRI (no certain implanted metal devices) and you do not have ongoing dangerous heart rhythm problems

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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