Clinical trial NCT06823635: An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects
Official title: An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Perimembranous Ventricular Septal Defect
Keywords: Cardiovascular Abnormalities
Congenital Heart Disease
Device Closure
Heart Defects, Congenital
Heart Septal Defects
Heart Septal Defects, Ventricular
Transcatheter Interventions
Ventricular Septal Defects
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2025-02-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

Brief summary: 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).

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with perimembranous ventricular septal defects (PmVSD), as defined by 2D transthoracic echocardiography according to previously published classifications.
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:

1. Eisenmenger physiology (pulmonary vascular resistance \> 8 Wood units, nonreactive) with an exclusive right-to-left shunt.
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

Primary outcomes:
measure: Twelve-month composite non-hierarchical clinical success
timeFrame: From implant attempt to 12 hours post-procedure
measure: Technical success
timeFrame: From implant attempt to 12 hours post-procedure
measure: Closure success
timeFrame: From implant attempt to 12 hours post-procedure
measure: Procedural success
timeFrame: From implant attempt to 12 hours post-procedure
measure: Clinical success
timeFrame: From implant attempt to 12-month post-procedure
measure: Freedom from procedure or device-related major adverse events
timeFrame: From implant attempt to 12-month post-procedure
Secondary outcomes:
measure: Short-term complications (≤30 days)
timeFrame: From implant attempt to 30 days post-procedure
measure: Long-term outcomes
timeFrame: From implant attempt to 60-month post-procedure
measure: Rate of incomplete closure at the 24-month follow-up.
timeFrame: From implant attempt to 24-month post-procedure
measure: Functional and quality-of-life measures
timeFrame: From implant attempt to 48-month post-procedure
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
city: Bordeaux
country: France
facility: University Hospital of Bordeaux
city: Le Plessis-Robinson
country: France
facility: Marie Lannelongue Hospital
city: Lille
country: France
facility: Lille University Hospital
city: Toulouse
country: France
facility: Toulouse University Hospital
city: Tuebingen
country: Germany
facility: University Children's Hospital
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center of Harapan Kita
city: Tehran
country: Iran, Islamic Republic of
facility: Rajaie Cardiovascular, Medical and Research Center
city: Beirut
country: Lebanon
facility: Hôtel-Dieu de France University Medical Center
city: Chiapas
country: Mexico
facility: Hospital de Especialidades Pediátricas
city: Lahore
country: Pakistan
facility: The Children's Hospital
city: Zabrze
country: Poland
facility: Silesian Center for Heart Diseases
city: Madinah
country: Saudi Arabia
facility: Madinah Cardiac Center MCC
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: Istanbul
country: Turkey
facility: Koç University
city: Istanbul
country: Turkey
facility: Umraniye Training and Education Hospital
city: Izmir
country: Turkey
facility: SBU Tepecik Training and Research Hospital
city: Dubai
country: United Arab Emirates
facility: Al Jalila Children's Speciality Hospital
Study officials:
affiliation: Marie Lannelongue Hospital
name: Raymond N. Haddad, MD, MHSc
role: PRINCIPAL_INVESTIGATOR
References: