An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects
NCT ID: NCT06823635
Last Updated: 2025-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1000 participants
OBSERVATIONAL
2025-03-01
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients with perimembranous ventricular septal defects (PmVSDs) who provided informed consent and u
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
2. Defect size between 3 mm and \<20 mm on the left ventricular side, as measured by 2D echocardiography.
3. Left-to-right ventricular shunt.
4. Age ≥3 months and body weight≥5 kg.
5. Symptomatic patients (heart failure, failure to thrive, recurrent respiratory infections, and rest or exercise dyspnea) or asymptomatic patients with progressive heart enlargement.
6. 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).
7. Presence or absence of aortic valve prolapse, with or without regurgitation.
8. Presence or absence of a membranous septal aneurysm, with or without inlet or outlet extension.
Exclusion Criteria
2. Pre-existing complete heart block or high-risk proximity of the conduction system to the defect without prior pacemaker implantation.
3. Severe aortic or tricuspid valve disease requiring surgical or catheter-based intervention.
4. Pregnancy or planned pregnancy if the procedure involves X-ray exposure.
5. Extensive congenital cardiac anomalies requiring surgery.
6. Thrombus at the implant site or documented venous thrombus in access vessels.
7. Sepsis, active endocarditis, or bacterial infections within one month pre-procedure.
8. Uncontrolled bleeding or clotting disorders.
9. Contraindications to antiplatelet therapy or refusal of blood transfusions.
10. Cardiac malformations dependent on the presence of a perimembranous ventricular septal defect (PmVSD).
11. Lack of informed written consent for the procedure
12. Failure to attend any follow-up visit post-discharge.
13. Patients under guardianship or curatorship
14. Patients deprived of liberty
15. Patients under court protection
16. Patients or legal guardians refusing the use of personal data for this research
3 Months
ALL
No
Sponsors
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Fondation Hôpital Saint-Joseph
OTHER
Responsible Party
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Principal Investigators
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Raymond N. Haddad, MD, MHSc
Role: PRINCIPAL_INVESTIGATOR
Marie Lannelongue Hospital
Locations
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Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
University Hospital of Bordeaux
Bordeaux, , France
Marie Lannelongue Hospital
Le Plessis-Robinson, , France
Lille University Hospital
Lille, , France
Toulouse University Hospital
Toulouse, , France
University Children's Hospital
Tübingen, , Germany
National Cardiovascular Center of Harapan Kita
Jakarta, , Indonesia
Rajaie Cardiovascular, Medical and Research Center
Tehran, , Iran
Hôtel-Dieu de France University Medical Center
Beirut, , Lebanon
Hospital de Especialidades Pediátricas
Chiapas, , Mexico
The Children's Hospital
Lahore, , Pakistan
Silesian Center for Heart Diseases
Zabrze, , Poland
Madinah Cardiac Center MCC
Madinah, , Saudi Arabia
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Koç University
Istanbul, , Turkey (Türkiye)
Umraniye Training and Education Hospital
Istanbul, , Turkey (Türkiye)
SBU Tepecik Training and Research Hospital
Izmir, , Turkey (Türkiye)
Al Jalila Children's Speciality Hospital
Dubai, , United Arab Emirates
Countries
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Central Contacts
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Other Identifiers
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PERI-CLOSE
Identifier Type: -
Identifier Source: org_study_id
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