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

NCT07791069 | Enrolling By Invitation DMC

• 2 other identifiers: RESTRICT33071272
• Study Type: observational
• Target: 150
• Locations: 4 countries
• Sites: 4

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.

Conditions

Congenital Heart Disease

Keywords

Pulmonary flow restriction; microvascular plug; pulmonary artery banding; staged palliation; single-ventricle physiology

Outcome Measures

Primary Outcomes (1)

• 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).

  From date of device implant until the date of surgical device removal, assessed up to 24 months

Secondary Outcomes (4)

• Technical implantation success

  From date of device implant until hospital discharge, assessed up to 6 weeks

• Immediate flow restriction success

  From device implant to procedure conclusion

• Safety success

  From date of device implant until the date of surgical device removal, assessed up to 24 months

• All cause mortality

  From date of device implant until the date of surgical device removal, assessed up to 24 months

Other Outcomes (2)

• Freedom from unplanned pulmonary artery (PA) reintervention

  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

  From date of surgical device removal through 24 months after removal

Interventions

Transcatheter pulmonary flow restriction DEVICE

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

Eligibility Criteria

• Age: Up to 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Study device implanted in other locations: modified BT shunt, arterial duct, stented arterial duct, Sano conduit, and central shunt.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (4)

Marie Lannelongue Hospital

Le Plessis-Robinson, France

Location

Mother and Child Health Institute of Serbia

Belgrade, Serbia

Location

Al Jalila Children's Specialty Hospital

Dubai, United Arab Emirates

Location

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Raymond N. Haddad, MD, MHSc, PhDc

  Marie Lannelongue Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): May 30, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: August 27, 2026

Record last verified: 2026-08

Locations

SE (1); AE (1); GB (1); FR (1)