An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects (PERI-CLOSE)

August 24, 2026 updated by: Fondation Hôpital Saint-Joseph
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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Recruiting
        • Copenhagen University Hospital, Rigshospitalet
  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Magdi Yacoub Heart Foundation
  • France
      • Bordeaux, France
        • Enrolling by invitation
        • University Hospital of Bordeaux
      • Le Plessis-Robinson, France
        • Recruiting
        • Marie Lannelongue Hospital
      • Lille, France
        • Recruiting
        • Lille University Hospital
      • Toulouse, France
        • Recruiting
        • Toulouse University Hospital
  • Germany
      • Tübingen, Germany
        • Recruiting
        • University Children's Hospital
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
      • Kowloon Bay, Hong Kong
        • Recruiting
        • Hong Kong Children's Hospital
  • Indonesia
      • Jakarta, Indonesia
        • Recruiting
        • National Cardiovascular Center of Harapan Kita
  • Iran
      • Tehran, Iran
        • Recruiting
        • Rajaie Cardiovascular, Medical and Research Center
  • Lebanon
      • Beirut, Lebanon
        • Recruiting
        • Hôtel-Dieu de France University Medical Center
  • Mexico
      • Chiapas, Mexico
        • Recruiting
        • Hospital de Especialidades Pediátricas
  • Pakistan
      • Lahore, Pakistan
        • Enrolling by invitation
        • The Children's Hospital
  • Poland
      • Zabrze, Poland
        • Recruiting
        • Silesian Center for Heart Diseases
  • Saudi Arabia
      • Madinah, Saudi Arabia
        • Recruiting
        • Madinah Cardiac Center MC
  • Sweden
      • Skåne, Sweden
        • Recruiting
        • Skane University Hospital
  • Switzerland
      • Zurich, Switzerland
        • Recruiting
        • University Children's Hospital of Zurich
  • Thailand
      • Nonthaburi, Thailand
        • Recruiting
        • Queen Sirikit National Institute of Child Health
      • Songkhla, Thailand
        • Recruiting
        • Prince of Songkla University
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • Ankara City Hospital
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Koç University
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Umraniye Training and Education Hospital
      • Izmir, Turkey (Türkiye)
        • Recruiting
        • SBU Tepecik Training and Research Hospital
  • United Arab Emirates
      • Dubai, United Arab Emirates
        • Recruiting
        • Al Jalila Children's Speciality Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-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.

Description

Inclusion Criteria:

  1. 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.
  2. Defect size between 3 mm and <20 mm on the left ventricular side, as measured by 2D echocardiography.
  3. Age ≥1 month and body weight ≥5 kg.
  4. Left-to-right ventricular shunt.

Exclusion Criteria:

  1. Patients or legal guardians refusing the use of personal data for research purposes.
  2. Failure to attend any follow-up visit post-discharge.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with PmVSDs who provided informed consent and underwent transcatheter closure
Device: Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)
Transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using an occluder device either specifically designed for this purpose or used off-label.
Other Names:
  • Percutaneous closure of perimembranous ventricular septal defects
  • Endovascular closure of perimembranous ventricular septal defects

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
From implant attempt to 12 months following index procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Technical success
Time Frame: From implant attempt to procedure conclusion
Successful device deployment and release into the intented position with stable device position confirmed via post-procedure transthoracic echocardiography (TTE).
From implant attempt to procedure conclusion
Closure success
Time Frame: From implant attempt to 12 months following index procedure
Complete shunt occlusion or trivial shunt on post-procedure TTE
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

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
From implant attempt to 12 months following index procedure
Minor complications
Time Frame: From implant attempt to 60 months following index procedure
Minor vascular complications (hematoma, pseudoaneurysm, minor bleeding). Transient arrhythmias (supraventricular tachycardia, non-sustained VT, first-degree AV block).
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

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
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
Change in NYHA/ROSS functional class, and in pediatric patients, catch-up growth.
From implant attempt to 48-month post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondation Hôpital Saint-Joseph

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raymond N. Haddad, MD, MHSc, PhDc, Marie Lannelongue Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 31, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 25, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PERI-CLOSE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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