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Enrolling By Invitation NCT07791069

International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease

Conditions: Congenital Heart Disease

Sex: All
Ages: N/A – 3 Years
Healthy volunteers: No
Enrollment: 150
Sponsor: Fondation Hôpital Saint-Joseph

Location: Marie Lannelongue Hospital Le Plessis-Robinson

Summary

The international multicenter registry aims to collect real-world data on clinical outcomes and evaluate the net clinical success of transcatheter microvascular plug (MVP)-based pulmonary flow restrictors (PFRs) in patients with congenital and acquired heart disease.

Eligibility Criteria

Inclusion Criteria: * Pediatric patients (≤3 years) with any congenital or acquired heart disease, regardless of gender, ethnicity, or geographic location, who underwent transcatheter insertion of the MVP-based PFR device in single or bilateral PA branches between January 2019 and January 2028. * Informed consent obtained from parents or legal guardians. Exclusion Criteria: * Study device implanted in other locations: modified BT shunt, arterial duct, stented arterial duct, Sano conduit, and central shunt.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07791069). StuddyBuddy aggregates publicly available trial information.