Congenital Heart Disease
Conditions
Keywords
Pulmonary flow restriction, microvascular plug, pulmonary artery banding, staged palliation, single-ventricle physiology
Brief 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.
Detailed description
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.
Interventions
DEVICETranscatheter pulmonary flow restriction
Transcatheter implantation of a microvascular plug (MVP)-based pulmonary flow restrictor (PFR) in a single or bilateral pulmonary artery (PA) branch(es).
Sponsors
Fondation Hôpital Saint-Joseph
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net clinical success | From date of device implant until the date of surgical device removal, assessed up to 24 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Technical implantation success | From date of device implant until hospital discharge, assessed up to 6 weeks | Technical success of PFR implantation (device successfully delivered, deployed, and retained in each branch PA) at hospital discharge after the index procedure. |
| Immediate flow restriction success | From device implant to procedure conclusion | 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%). |
| Safety success | From date of device implant until the date of surgical device removal, assessed up to 24 months | 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. |
| All cause mortality | From date of device implant until the date of surgical device removal, assessed up to 24 months | All-cause mortality rate at the time of device removal. |
Countries
France, Germany, Serbia, United Arab Emirates, United Kingdom
Contacts
PRINCIPAL_INVESTIGATORRaymond N. Haddad, MD, MHSc, PhDc
Marie Lannelongue Hospital, INSERM, UMR-S1358, UP-Saclay
Outcome results
None listed