Trials Sponsors Conditions Drugs Pricing

Conditions

Perimembranous Ventricular Septal Defect

Keywords

Cardiovascular AbnormalitiesCongenital Heart DiseaseDevice ClosureHeart Defects, CongenitalHeart Septal DefectsHeart Septal Defects, VentricularTranscatheter InterventionsVentricular Septal Defects

Outcome Measures

Primary Outcomes (1)

Twelve-month composite non-hierarchical net clinical success
Defined as simultaneous achievement of technical implantation success at procedure conclusion (device successfully deployed and released in the intended position), closure success (complete occlusion or trivial residual shunt), and absence of major adverse device-related events (MADREs), through 12 months.
From implant attempt to 12 months following index procedure

Secondary Outcomes (6)

Technical success
From implant attempt to procedure conclusion
Closure success
From implant attempt to 12 months following index procedure
Freedom from major device-related major adverse events
From implant attempt to 12 months following index procedure
Minor complications
From implant attempt to 60 months following index procedure
Late-onset device-related major adverse events (MADREs)
From 12 months to 60 months following index procedure
+1 more secondary outcomes

Study Arms (1)

Patients with PmVSDs who provided informed consent and underwent transcatheter closure

Device: Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)

Interventions

Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)Device

Transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using an occluder device either specifically designed for this purpose or used off-label.

Also known as: Percutaneous closure of perimembranous ventricular septal defects, Endovascular closure of perimembranous ventricular septal defects

Patients with PmVSDs who provided informed consent and underwent transcatheter closure

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

Eligibility Criteria

Age1 Month+

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients, regardless of gender or geographical location, with perimembranous ventricular septal defects (PmVSDs) who provided informed consent and underwent transcatheter closure using commercially available occluder devices, whether specifically designed for this purpose or used off-label, were followed according to local hospital protocols.

You may qualify if:

Sponsors & Collaborators

Fondation Hôpital Saint-Joseph
Otherlead

Study Sites (25)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

RECRUITING

Magdi Yacoub Heart Foundation

Cairo, Egypt

RECRUITING

University Hospital of Bordeaux

Bordeaux, France

ENROLLING_BY_INVITATION

Marie Lannelongue Hospital

Le Plessis-Robinson, France

MeSH Terms

Conditions

Cardiovascular AbnormalitiesHeart Defects, CongenitalHeart Septal DefectsHeart Septal Defects, Ventricular

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHeart Diseases

Study Officials

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

Central Study Contacts

Raymond N. Haddad, MD, MHSc, PhDc

CONTACT

+33140942800 raymondhaddad@live.com

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: RETROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 12, 2025

Study Start

January 1, 2025

Actual (reported)

Primary Completion

December 31, 2026

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Patients with PmVSDs who provided informed consent and underwent transcatheter closure

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (1)

Patients with PmVSDs who provided informed consent and underwent transcatheter closure

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (25)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations