An observational study in Congenital Heart Disease, sponsored by Fondation Hôpital Saint-Joseph. Enrolling by invitation at 5 sites in 5 countries. Open to participants aged Up to 3 Years. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by Fondation Hôpital Saint-Joseph · Observational
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.
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.
Exclusion Criteria:
Transcatheter implantation of a microvascular plug (MVP)-based pulmonary flow restrictor (PFR) in a single or bilateral pulmonary artery (PA) branch(es).
Also known as: Percutaneous pulmonary flow restriction, Endovascular pulmonary flow restriction
Net clinical success
Composite non-hierarchical net clinical success, evaluated at the time of surgical PFR removal (either as a standalone procedure or during target surgery), and defined by meeting the following three criteria: 1) technical success (successful implantation and retention\* of the MVP device in each branch PA), 2) clinical success (evidence of PBF restriction\*\* at PFR removal), and 3) safety success (no major adverse device-related events (MADREs).
Time frame: From date of device implant until the date of surgical device removal, assessed up to 24 months
Technical implantation success
Technical success of PFR implantation (device successfully delivered, deployed, and retained in each branch PA) at hospital discharge after the index procedure.
Time frame: From date of device implant until hospital discharge, assessed up to 6 weeks
Immediate flow restriction success
Immediate flow restriction success of MVP-based PFRs, defined as technical success and evidence of pulmonary blood flow (BPF) restriction, at procedure conclusion (Evidence of PBF restriction at procedure conclusion was defined as a minimal drop in oxygen saturation on arterial blood gas by 10% at the same level of FiO2 compared to preoperative levels, a systolic-diastolic Doppler-pattern across the PFRs with a minimum peak Doppler gradient of 40 mmHg (Vmax=3.2 m/s) on per-procedural ultrasound assessment, and, when performed, a reduction in the baseline QP/QS mismatch by 50%).
Time frame: From device implant to procedure conclusion
Safety success
Safety success (freedom from MADREs\*, vascular-, or procedure-related SAEs\*\*) at the time of device removal. The severity of MADRE and SAE will be classified using a validated 1-to-5 scale, ranging from none to catastrophic. \*MADREs include device-related vascular erosion, vascular aneurysm/pseudoaneurysm, bronchial compression, device collapse, migration, embolization, thrombosis, fracture, infection, endocarditis, resulting in unplanned or anticipated device removal, or redo-intervention (surgical or catheter-based) \*\*SAEs encompassed device- vascular- or procedure-related adverse events resulting in death, life-threatening situations, hospitalization, disability, or major surgical intervention.
Time frame: From date of device implant until the date of surgical device removal, assessed up to 24 months
All cause mortality
All-cause mortality rate at the time of device removal.
Time frame: From date of device implant until the date of surgical device removal, assessed up to 24 months
Freedom from unplanned pulmonary artery (PA) reintervention
Freedom from unplanned PA reintervention (surgical or catheter-based) until surgical device removal
Time frame: From date of device implant until the date of surgical device removal, assessed up to 24 months
Freedom from unplanned pulmonary artery intervention post-device removal
Freedom from unplanned PA intervention at 24 months following surgical device removal (such as angioplasty or stenting for residual stenosis or deformity at the former device site).
Time frame: From date of surgical device removal through 24 months after removal
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Fondation Hôpital Saint-Joseph