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

Overview

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.

Interventions

• Device 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.

Primary outcome measures

• Twelve-month composite non-hierarchical clinical success [Time frame: From implant attempt to 12 hours post-procedure]
• Technical success [Time frame: From implant attempt to 12 hours post-procedure]
• Closure success [Time frame: From implant attempt to 12 hours post-procedure]
• Procedural success [Time frame: From implant attempt to 12 hours post-procedure]
• Clinical success [Time frame: From implant attempt to 12-month post-procedure]
• Freedom from procedure or device-related major adverse events [Time frame: From implant attempt to 12-month post-procedure]

Secondary outcome measures (4)

• Short-term complications (≤30 days) [Time frame: From implant attempt to 30 days post-procedure]
• Long-term outcomes [Time frame: From implant attempt to 60-month post-procedure]
• Rate of incomplete closure at the 24-month follow-up. [Time frame: From implant attempt to 24-month post-procedure]
• Functional and quality-of-life measures [Time frame: From implant attempt to 48-month post-procedure]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

France · 4 centers

• University Hospital of Bordeaux — Bordeaux
• Marie Lannelongue Hospital — Le Plessis-Robinson
• Lille University Hospital — Lille
• Toulouse University Hospital — Toulouse

Turkey (Türkiye) · 4 centers

• Ankara City Hospital — Ankara
• Koç University — Istanbul
• Umraniye Training and Education Hospital — Istanbul
• SBU Tepecik Training and Research Hospital — Izmir

Denmark · 1 center

• Copenhagen University Hospital, Rigshospitalet — Copenhagen

Germany · 1 center

• University Children's Hospital — Tübingen

Indonesia · 1 center

• National Cardiovascular Center of Harapan Kita — Jakarta

Iran · 1 center

• Rajaie Cardiovascular, Medical and Research Center — Tehran

Lebanon · 1 center

• Hôtel-Dieu de France University Medical Center — Beirut

Mexico · 1 center

• Hospital de Especialidades Pediátricas — Chiapas

Pakistan · 1 center

• The Children's Hospital — Lahore

Poland · 1 center

• Silesian Center for Heart Diseases — Zabrze

Saudi Arabia · 1 center

• Madinah Cardiac Center MCC — Madinah

United Arab Emirates · 1 center

• Al Jalila Children's Speciality Hospital — Dubai

Identifiers

NCT: NCT06823635 · PERI-CLOSE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗