Clin2
NCT07532369Worth exploringNot yet recruiting

Study of heart device for Fontan procedure patients

Failure of Fontan Type CirculationFenestrationUniventricular HeartCongenital Anomaly

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

This study follows patients who received an AFR device (a special catheter-based implant) to help improve blood flow in their heart after a Fontan surgery. Researchers want to understand how well the device works and its safety over time.

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

Phase
N/A
Enrollment
25 people
Ages
Any age
Study type
Observational

Who can take part

  • You received an AFR device through the FDA's Expanded Access Program for a failing Fontan procedure (either the device was successfully placed or an attempt was made)
  • You or your legal guardian must be willing to sign a consent form agreeing to participate
  • You must understand the study's purpose and procedures before enrolling

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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