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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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
Intervention / Treatment
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

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

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

Fondation Hôpital Saint-Joseph

Investigators

  • 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)

January 1, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

January 31, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

Subscribe