Perimembranous Ventricular Septal DefectPERI-CLOSENCT06823635
An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects
An observational study of Perimembranous Ventricular Septal Defect, run by Fondation Hôpital Saint-Joseph at 25 sites in 17 countries.
Trial summary
The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD). Read more about this study
- Who is it for?
- Ages 1 month and older
- Conditions the study is for
- Perimembranous Ventricular Septal Defect
- What is being tested?
- Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)
- Type of treatment
- Medical device
- How many people
- 2,000 participants
- Where
- 25 sitesin 17 countries
- Study dates
- 1 Jan 2025to 30 Jun 2027
- 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 1 month and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Patients with perimembranous ventricular septal defects (PmVSD) diagnosed by 2D transthoracic echocardiography according to established classification systems, who provided informed consent and underwent transcatheter closure using any commercially available occluder devices (whether specifically designed for this indication or used off-label), with follow-up according to local hospital protocols.
- Defect size between 3 mm and <20 mm on the left ventricular side, as measured by 2D echocardiography.
- Age ≥1 month and body weight ≥5 kg.
- Left-to-right ventricular shunt.
Who cannot join
- Patients or legal guardians refusing the use of personal data for research purposes.
- Failure to attend any follow-up visit post-discharge.
Trial locations and contacts
25 sites in 17 countries. Contact the study team or a site near you to ask about taking part.
25 sites in 17 countries
France4 sites, 4 recruiting
- Enrolling by invitation
University Hospital of Bordeaux
Bordeaux
- Recruiting
Marie Lannelongue Hospital
Le Plessis-Robinson
- Recruiting
Lille University Hospital
Lille
- Recruiting
Toulouse University Hospital
Toulouse
Turkey (Türkiye)4 sites, 4 recruiting
- Recruiting
Ankara City Hospital
Ankara
- Recruiting
Koç University
Istanbul
- Recruiting
Umraniye Training and Education Hospital
Istanbul
- Recruiting
SBU Tepecik Training and Research Hospital
Izmir
Hong Kong2 sites, 2 recruiting
- Recruiting
Queen Mary Hospital
Hong Kong
- Recruiting
Hong Kong Children's Hospital
Kowloon Bay
Thailand2 sites, 2 recruiting
- Recruiting
Queen Sirikit National Institute of Child Health
Nonthaburi
- Recruiting
Prince of Songkla University
Songkhla
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital, Rigshospitalet
Copenhagen
Indonesia1 site, 1 recruiting
- Recruiting
National Cardiovascular Center of Harapan Kita
Jakarta
Iran1 site, 1 recruiting
- Recruiting
Rajaie Cardiovascular, Medical and Research Center
Tehran
Lebanon1 site, 1 recruiting
- Recruiting
Hôtel-Dieu de France University Medical Center
Beirut
Mexico1 site, 1 recruiting
- Recruiting
Hospital de Especialidades Pediátricas
Chiapas
Pakistan1 site, 1 recruiting
- Enrolling by invitation
The Children's Hospital
Lahore
Saudi Arabia1 site, 1 recruiting
- Recruiting
Madinah Cardiac Center MC
Madinah
Switzerland1 site, 1 recruiting
- Recruiting
University Children's Hospital of Zurich
Zurich
United Arab Emirates1 site, 1 recruiting
- Recruiting
Al Jalila Children's Speciality Hospital
Dubai
About this study
The international multicenter registry aims to gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).
Read the detailed description
This is a non-randomized, multicenter, international, non-interventional, observational, retrospective post-marketing clinical follow-up study designed to evaluate the feasibility, safety, and efficacy of transcatheter closure of perimembranous ventricular septal defects (PmVSD) using commercially available device occluders, whether specifically designed for this purpose or used off-label.
- Conditions
- Perimembranous Ventricular Septal Defect
- Being tested
- Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)
- Keywords
- Cardiovascular Abnormalities, Congenital Heart Disease, Device Closure, Heart Defects, Congenital, Heart Septal Defects, Heart Septal Defects, Ventricular, Transcatheter Interventions, Ventricular Septal Defects
- Medical subject headings
- Cardiovascular Abnormalities, Heart Defects, Congenital, Heart Septal Defects, Heart Septal Defects, Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)Device
Also called Percutaneous closure of perimembranous ventricular septal defects, Endovascular closure of perimembranous ventricular septal defects
Transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using an occluder device either specifically designed for this purpose or used off-label.
| Study group | Role | What they receive |
|---|---|---|
| Patients with PmVSDs who provided informed consent and underwent transcatheter closure | Not described Receives: Device: Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From implant attempt to 12 months following index procedure
Secondary outcomes (6)
Technical success
Successful device deployment and release into the intented position with stable device position confirmed via post-procedure transthoracic echocardiography (TTE).
Measured: From implant attempt to procedure conclusion
Closure success
Complete shunt occlusion or trivial shunt on post-procedure TTE
Measured: From implant attempt to 12 months following index procedure
Freedom from major device-related major adverse events
Absence of procedure or device-related major adverse events, including:
- Device erosion
- Device migration or embolization requiring catheter or surgical intervention.
- Complete heart block requiring permanent pacemaker implantation, device removal, or other medical treatment.
- New or worsened aortic regurgitation (of mild grade or greater) requiring device removal, close monitoring, or intervention.
- New or worsened tricuspid regurgitation (of moderate grade or greater) requiring device removal, close monitoring, or intervention.
- Life-threatening bleeding or significant vascular injury requiring catheter or surgical intervention.
- Thromboembolic events requiring device removal, thrombolytic therapy, catheter, or surgical intervention.
- Severe acute hemolysis, requiring blood transfusion device removal, catheter, or surgical intervention.
- Device-related left or right ventricular outflow tract obstruction
- Cardiac tamponade
Measured: From implant attempt to 12 months following index procedure
Minor complications
Minor vascular complications (hematoma, pseudoaneurysm, minor bleeding). Transient arrhythmias (supraventricular tachycardia, non-sustained VT, first-degree AV block).
Measured: From implant attempt to 60 months following index procedure
Late-onset device-related major adverse events (MADREs)
Absence of procedure or device-related major adverse events, including:
- Device erosion
- Device migration or embolization requiring catheter or surgical intervention.
- Complete heart block requiring permanent pacemaker implantation, device removal, or other medical treatment.
- New or worsened aortic regurgitation (of mild grade or greater) requiring device removal, close monitoring, or intervention.
- New or worsened tricuspid regurgitation (of moderate grade or greater) requiring device removal, close monitoring, or intervention.
- Life-threatening bleeding or significant vascular injury requiring catheter or surgical intervention.
- Thromboembolic events requiring device removal, thrombolytic therapy, catheter, or surgical intervention.
- Severe acute hemolysis, requiring blood transfusion device removal, catheter, or surgical intervention.
- Device-related left or right ventricular outflow tract obstruction
- Cardiac tamponade
- Death
Measured: From 12 months to 60 months following index procedure
Functional and quality-of-life measures
Change in NYHA/ROSS functional class, and in pediatric patients, catch-up growth.
Measured: From implant attempt to 48-month post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perimembranous Ventricular Septal DefectStudies 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
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
- NCT06823635
- Sponsor's protocol ID
- PERI-CLOSE
- Acronym
- PERI-CLOSE
- Status last verified
- Sep 2026
- First submitted
- 31 Jan 2025
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects
- ClinicalTrials.gov ID
- NCT06823635
- Acronym / sponsor ID
- PERI-CLOSE / PERI-CLOSE
- Conditions
- Perimembranous Ventricular Septal Defect
- Keywords
- Cardiovascular Abnormalities, Congenital Heart Disease, Device Closure, Heart Defects, Congenital, Heart Septal Defects, Heart Septal Defects, Ventricular, Transcatheter Interventions, Ventricular Septal Defects
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Feb 2025 (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 gather real-world data on patient outcomes and assess the procedural success and performance of various device occluders used in the transcatheter treatment of pediatric and adult patients with perimembranous ventricular septal defects (PmVSD).
Detailed description
This is a non-randomized, multicenter, international, non-interventional, observational, retrospective post-marketing clinical follow-up study designed to evaluate the feasibility, safety, and efficacy of transcatheter closure of perimembranous ventricular septal defects (PmVSD) using commercially available device occluders, whether specifically designed for this purpose or used off-label.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with PmVSDs who provided informed consent and underwent transcatheter closure | – | Device: Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs) |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- Patients with perimembranous ventricular septal defects (PmVSD) diagnosed by 2D transthoracic echocardiography according to established classification systems, who provided informed consent and underwent transcatheter closure using any commercially available occluder devices (whether specifically designed for this indication or used off-label), with follow-up according to local hospital protocols.
- Defect size between 3 mm and <20 mm on the left ventricular side, as measured by 2D echocardiography.
- Age ≥1 month and body weight ≥5 kg.
- Left-to-right ventricular shunt.
Key exclusion criteria (2 listed)
- Patients or legal guardians refusing the use of personal data for research purposes.
- Failure to attend any follow-up visit post-discharge.
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 device closure of perimembranous ventricular septal defects (PmVSDs)Also: Percutaneous closure of perimembranous ventricular septal defects, Endovascular closure of perimembranous ventricular septal defectsTranscatheter closure of perimembranous ventricular septal defects (PmVSDs) using an occluder device either specifically designed for this purpose or used off-label. | Device | Patients with PmVSDs who provided informed consent and underwent transcatheter closure |
Primary outcome
Twelve-month composite non-hierarchical net clinical success
Time frame: From implant attempt to 12 months following index procedure
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.
6 secondary outcomes
Technical success
Time frame: From implant attempt to procedure conclusion
Closure success
Time frame: From implant attempt to 12 months following index procedure
Freedom from major device-related major adverse events
Time frame: From implant attempt to 12 months following index procedure
Minor complications
Time frame: From implant attempt to 60 months following index procedure
Late-onset device-related major adverse events (MADREs)
Time frame: From 12 months to 60 months following index procedure
Functional and quality-of-life measures
Time frame: From implant attempt to 48-month post-procedure
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 8 Sep 2026.
- Individual participant dataSharing planned: No
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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
25 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perimembranous Ventricular Septal Defect, run by Fondation Hôpital Saint-Joseph at 25 sites in 17 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 8 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 25 sites in France, Turkey (Türkiye), Hong Kong, Thailand, Denmark and 12 more countries. 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?
Contact Raymond N. Haddad, MD, MHSc, PhDc (+33140942800, raymondhaddad@live.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Twelve-month composite non-hierarchical net clinical success (time frame: From implant attempt to 12 months following index procedure). 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 8 Sep 2026.