Clin2
NCT02744677Possibly a fitRecruiting

Pulmonary valve procedure to improve blood flow issues

Complex Congenital Heart DefectDysfunctional RVOT ConduitPulmonary Valve InsufficiencyPulmonary Valve Degeneration

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

This trial studies a transcatheter pulmonary valve (a valve placed through a catheter) in people whose right-sided outflow tract valve/conduit is not working well. It aims to improve blood flow and reduce pressure problems, while checking safety and results after the procedure.

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

Phase
N/A
Enrollment
108 people
Ages
Any age
Study type
Interventional

Who can take part

  • Your weight is at least 20 kg (44 lbs).
  • You have a problem valve/conduit in the pulmonary position that doctors feel needs treatment.
  • Your tests show at least moderate “PR” and/or a mean RVOT pressure gradient of 35 mmHg or higher.
  • You can have the procedure because your body size and anatomy fit the device route through the groin (femoral access).
  • You are able to give consent (or your legal representative can).
  • You must be free of key exclusions like active infection, certain blood/bleeding problems, drug use, and pregnancy/lactation.

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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