Congenital Heart DiseaseRESTRICTNCT07791069
International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease
An observational study of Congenital Heart Disease, run by Fondation Hôpital Saint-Joseph at 5 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Transcatheter pulmonary flow restriction
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 1 Oct 2026to 1 Jan 2030
- How long will I take part?
- 24 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 3 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Study device implanted in other locations: modified BT shunt, arterial duct, stented arterial duct, Sano conduit, and central shunt.
Trial locations and contacts
5 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 5 countries
United Arab Emirates1 site
Al Jalila Children's Specialty Hospital
Dubai
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- Transcatheter pulmonary flow restriction
- Keywords
- Pulmonary flow restriction, microvascular plug, pulmonary artery banding, staged palliation, single-ventricle physiology
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter pulmonary flow restrictionDevice
Also called Percutaneous pulmonary flow restriction, Endovascular 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).
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From date of device implant until the date of surgical device removal, assessed up to 24 months
Secondary outcomes (4)
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.
Measured: 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%).
Measured: 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.
Measured: 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.
Measured: From date of device implant until the date of surgical device removal, assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 May 2029 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raymond N. Haddad, MD, MHSc, PhDc, Principal investigator, Marie Lannelongue Hospital, INSERM, UMR-S1358, UP-Saclay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07791069
- Sponsor's protocol ID
- RESTRICT
- Other IDs
- 33071272
- Acronym
- RESTRICT
- Status last verified
- Sep 2026
- First submitted
- 16 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTRICT : International Multicenter Outcomes of Transcatheter Pulmonary Flow Restrictors in Congenital and Acquired Heart Disease
- ClinicalTrials.gov ID
- NCT07791069
- Acronym / sponsor ID
- RESTRICT / RESTRICT
- Conditions
- Congenital Heart Disease
- Keywords
- Pulmonary flow restriction, microvascular plug, pulmonary artery banding, staged palliation, single-ventricle physiology
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 May 2029 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Study device implanted in other locations: modified BT shunt, arterial duct, stented arterial duct, Sano conduit, and central shunt.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcatheter pulmonary flow restrictionAlso: Percutaneous pulmonary flow restriction, Endovascular pulmonary flow restrictionTranscatheter implantation of a microvascular plug (MVP)-based pulmonary flow restrictor (PFR) in a single or bilateral pulmonary artery (PA) branch(es). | Device | – |
Primary outcome
Net clinical success
Time frame: 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).
4 secondary outcomes
Technical implantation success
Time frame: From date of device implant until hospital discharge, assessed up to 6 weeks
Immediate flow restriction success
Time frame: From device implant to procedure conclusion
Safety success
Time frame: From date of device implant until the date of surgical device removal, assessed up to 24 months
All cause mortality
Time frame: From date of device implant until the date of surgical device removal, assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raymond N. Haddad, MD, MHSc, PhDc principal investigator
Marie Lannelongue Hospital, INSERM, UMR-S1358, UP-Saclay
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Fondation Hôpital Saint-Joseph at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France, Germany, Serbia, United Arab Emirates, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Net clinical success (time frame: From date of device implant until the date of surgical device removal, assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.