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NCT Number: NCT06823635

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

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).

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Key information

Conditions

Perimembranous Ventricular Septal Defect Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Septal Defects Heart Septal Defects, Ventricular

Age range

1 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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.

Other names: Percutaneous closure of perimembranous ventricular septal defects, Endovascular closure of perimembranous ventricular septal defects

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. Closure success

    Time frame: From implant attempt to 12 months following index procedure

    Complete shunt occlusion or trivial shunt on post-procedure TTE

  3. 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

  4. 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).

  5. 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

  6. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Raymond N. Haddad, MD, MHSc, PhDc

CONTACT

[email protected]

+33140942800

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: PERI-CLOSE

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 12, 2025
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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