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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3+
SponsorFondation Hôpital Saint-Joseph

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)

Treatment groups

1,000 Participants
are divided into 1 treatment group