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