Trials Sponsors Conditions Drugs Pricing

Conditions

Congenital Heart Disease

Keywords

Pulmonary flow restrictionmicrovascular plugpulmonary artery bandingstaged palliationsingle-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 restrictionDevice

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

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

AgeUp to 3 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

Sampling MethodNon-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.

Sponsors & Collaborators

Fondation Hôpital Saint-Joseph
Otherlead

Study Sites (5)

Marie Lannelongue Hospital

Le Plessis-Robinson, France

University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Mother and Child Health Institute of Serbia

Belgrade, Serbia

Al Jalila Children's Specialty Hospital

Dubai, United Arab Emirates

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

Raymond N. Haddad, MD, MHSc, PhDc
Marie Lannelongue Hospital, INSERM, UMR-S1358, UP-Saclay
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

October 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Primary Completion

May 30, 2029

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Other Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (5)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations