An International Multicenter Study on Transcatheter Device Closure of Perimembranous Ventricular Septal Defects (PERI-CLOSE)

Fondation Hôpital Saint-Joseph

Status: Not yet enrolling

Conditions: Perimembranous Ventricular Septal Defect

Treatments: Device: Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)

Study type: Observational

Funder types: Other

Identifiers

NCT06823635

PERI-CLOSE

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 3+ months old

Volunteers: No Healthy Volunteers

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

Trial design

1,000 participants in 1 patient group

Patients with perimembranous ventricular septal defects (PmVSDs) who provided informed consent and u

Treatment:

Device: Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)