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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

3 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), as defined by 2D transthoracic echocardiography according to previously published classifications.
  • Defect size between 3 mm and <20 mm on the left ventricular side, as measured by 2D echocardiography.
  • Left-to-right ventricular shunt.
  • Age ≥3 months and body weight≥5 kg.
  • Symptomatic patients (heart failure, failure to thrive, recurrent respiratory infections, and rest or exercise dyspnea) or asymptomatic patients with progressive heart enlargement.
  • History of infective endocarditis related to the PmVSD or hemodynamically significant PmVSD with: Qp/Qs >1.5 on catheterization, left ventricular volume overload (LVEDD z-score >2) based on echocardiography, or pulmonary hypertension on catheterization (mean pulmonary artery pressure >20 mmHg).
  • Presence or absence of aortic valve prolapse, with or without regurgitation.
  • Presence or absence of a membranous septal aneurysm, with or without inlet or outlet extension.

Exclusion criteria

  • Eisenmenger physiology (pulmonary vascular resistance > 8 Wood units, nonreactive) with an exclusive right-to-left shunt.
  • Pre-existing complete heart block or high-risk proximity of the conduction system to the defect without prior pacemaker implantation.
  • Severe aortic or tricuspid valve disease requiring surgical or catheter-based intervention.
  • Pregnancy or planned pregnancy if the procedure involves X-ray exposure.
  • Extensive congenital cardiac anomalies requiring surgery.
  • Thrombus at the implant site or documented venous thrombus in access vessels.
  • Sepsis, active endocarditis, or bacterial infections within one month pre-procedure.
  • Uncontrolled bleeding or clotting disorders.
  • Contraindications to antiplatelet therapy or refusal of blood transfusions.
  • Cardiac malformations dependent on the presence of a perimembranous ventricular septal defect (PmVSD).
  • Lack of informed written consent for the procedure
  • Failure to attend any follow-up visit post-discharge.
  • Patients under guardianship or curatorship
  • Patients deprived of liberty
  • Patients under court protection
  • Patients or legal guardians refusing the use of personal data for this research

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.

Primary outcomes

  1. Twelve-month composite non-hierarchical clinical success

    Time frame: From implant attempt to 12 hours post-procedure

    Defined as meeting the following 3 criteria: 1) technical success (device successfully implanted and retained at hospital discharge), 2) closure success (trivial or no residual shunt through 12 months), 3) safety success (no serious adverse events (SAEs) through 30 days, and no device events (removal or reintervention) through 12 months).

  2. Technical success

    Time frame: From implant attempt to 12 hours post-procedure

    Successful device deployment and stable device position confirmed via post-procedure transthoracic echocardiography (TTE).

  3. Closure success

    Time frame: From implant attempt to 12 hours post-procedure

    Complete shunt occlusion or trivial shunt on post-procedure TTE

  4. Procedural success

    Time frame: From implant attempt to 12 hours post-procedure

    Technical success with complete closure of PmVSD (residual shunt ≤2 mm confirmed on post-procedure TTE), no interference with adjacent structures, including aortic and tricuspid valves.

  5. Clinical success

    Time frame: From implant attempt to 12-month post-procedure

    In symptomatic patients: Resolution of patient-reported clinical symptoms (reduced fatigue, improved exercise tolerance) within 30 days, along with normalization of left ventricular dimensions on cardiac ultrasound, and/or a ≥20% reduction in pulmonary artery pressure from baseline.

  6. Freedom from procedure or device-related major adverse events

    Time frame: From implant attempt to 12-month post-procedure

    Absence of procedure or device-related major adverse events, including:

    • Device migration or embolization requiring catheter or surgical intervention.
    • Complete heart block requiring permanent pacemaker implantation, device removal, or other medical treatment.
    • Severe aortic or tricuspid regurgitation (≥ moderate grade) requiring device removal, close monitoring, or intervention.
    • Life-threatening bleeding or significant vascular injury requiring catheter or surgical intervention.
    • Thrombosis of device or vascular access that requires device removal, thrombolytic therapy, catheter, or surgical intervention.
    • Severe acute hemolysis, requiring blood transfusion device removal, catheter, or surgical intervention.

Secondary outcomes

  1. Short-term complications (≤30 days)

    Time frame: From implant attempt to 30 days post-procedure

    Minor vascular complications (hematoma, pseudoaneurysm, minor bleeding). Transient arrhythmias (supraventricular tachycardia, non-sustained VT, first-degree AV block).

  2. Long-term outcomes

    Time frame: From implant attempt to 60-month post-procedure

    • Sustained complete closure (no or minimal residual shunt on TTE).
    • Late-onset device-related complications (new-onset aortic or tricuspid regurgitation, delayed second-degree or complete heart block, or arrhythmias requiring permanent treatment).
    • Device migration or embolization requiring catheter or surgical removal
    • Thromboembolism: thrombosis of device or vascular access that requires thrombolytic therapy
    • Hemolysis requiring prolonged or redo hospitalization and severe acute hemolysis requiring blood transfusion with or without intervention.
    • Death

  3. Rate of incomplete closure at the 24-month follow-up.

    Time frame: From implant attempt to 24-month post-procedure

    Rate of incomplete closure at the 24-month follow-up: A significant shunt will be defined as ≥ moderate or requiring treatment (surgical or interventional). The residual shunt will be assessed using color Doppler echocardiography, with shunt size categorized according to previously published classifications.

  4. Functional and quality-of-life measures

    Time frame: From implant attempt to 48-month post-procedure

    Improvement 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.

Study Principal Investigator

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
2026
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

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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