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

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

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.

This is a multicenter, international, non-randomized, non-interventional, observational post-marketing clinical follow-up study with retrospective and prospective data collection, designed to evaluate the feasibility, safety, and efficacy of off-label implantation of microvascular plug (MVP)-based pulmonary flow restrictors (PFRs) in patients with congenital and acquired heart disease.

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.