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

NCT06823635 | Not Yet Recruiting

• 1 other identifier: PERI-CLOSE
• Study Type: observational
• Target: 1,000
• Locations: 12 countries
• Sites: 18

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).

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

Outcome Measures

Primary Outcomes (6)

• Twelve-month composite non-hierarchical clinical success

  Defined as meeting the following 3 criteria: 1) technical success (device successfully implanted and retained at hospital discharge), 2) closure success (trivial or no residual shunt through 12 months), 3) safety success (no serious adverse events (SAEs) through 30 days, and no device events (removal or reintervention) through 12 months).

  From implant attempt to 12 hours post-procedure

• Technical success

  Successful device deployment and stable device position confirmed via post-procedure transthoracic echocardiography (TTE).

  From implant attempt to 12 hours post-procedure

• Closure success

  Complete shunt occlusion or trivial shunt on post-procedure TTE

  From implant attempt to 12 hours post-procedure

• Procedural success

  Technical success with complete closure of PmVSD (residual shunt ≤2 mm confirmed on post-procedure TTE), no interference with adjacent structures, including aortic and tricuspid valves.

  From implant attempt to 12 hours post-procedure

• Clinical success

  In symptomatic patients: Resolution of patient-reported clinical symptoms (reduced fatigue, improved exercise tolerance) within 30 days, along with normalization of left ventricular dimensions on cardiac ultrasound, and/or a ≥20% reduction in pulmonary artery pressure from baseline.

  From implant attempt to 12-month post-procedure

• Freedom from procedure or device-related major adverse events

  Absence of procedure or device-related major adverse events, including: * Device migration or embolization requiring catheter or surgical intervention. * Complete heart block requiring permanent pacemaker implantation, device removal, or other medical treatment. * Severe aortic or tricuspid regurgitation (≥ moderate grade) requiring device removal, close monitoring, or intervention. * Life-threatening bleeding or significant vascular injury requiring catheter or surgical intervention. * Thrombosis of device or vascular access that requires device removal, thrombolytic therapy, catheter, or surgical intervention. * Severe acute hemolysis, requiring blood transfusion device removal, catheter, or surgical intervention.

  From implant attempt to 12-month post-procedure

Secondary Outcomes (4)

• Short-term complications (≤30 days)

  From implant attempt to 30 days post-procedure

• Long-term outcomes

  From implant attempt to 60-month post-procedure

• Rate of incomplete closure at the 24-month follow-up.

  From implant attempt to 24-month post-procedure

• Functional and quality-of-life measures

  From implant attempt to 48-month post-procedure

Study Arms (1)

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

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

Interventions

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

Transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using an occluder device either specifically designed for this purpose or used off-label.

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

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead

Study Sites (18)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark

Location

University Hospital of Bordeaux

Bordeaux, France

Location

Marie Lannelongue Hospital

Le Plessis-Robinson, France

Location

Lille University Hospital

Lille, France

Location

Toulouse University Hospital

Toulouse, France

Location

University Children's Hospital

Tübingen, Germany

Location

National Cardiovascular Center of Harapan Kita

Jakarta, Indonesia

Location

Rajaie Cardiovascular, Medical and Research Center

Tehran, Iran

Location

Hôtel-Dieu de France University Medical Center

Beirut, Lebanon

Location

Hospital de Especialidades Pediátricas

Chiapas, Mexico

Location

The Children's Hospital

Lahore, Pakistan

Location

Silesian Center for Heart Diseases

Zabrze, Poland

Location

Madinah Cardiac Center MCC

Madinah, Saudi Arabia

Location

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

Koç University

Istanbul, Turkey (Türkiye)

Location

Umraniye Training and Education Hospital

Istanbul, Turkey (Türkiye)

Location

SBU Tepecik Training and Research Hospital

Izmir, Turkey (Türkiye)

Location

Al Jalila Children's Speciality Hospital

Dubai, United Arab Emirates

Location

MeSH Terms

Conditions

Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects; Heart Septal Defects, Ventricular

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Diseases

Study Officials

• Raymond N. Haddad, MD, MHSc

  Marie Lannelongue Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Principal Investigator

CONTACT

+33140942800; raymondhaddad@live.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 12, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (4); AE (1); ID (1); DK (1); ME (1); SA (1); PL (1); LE (1); DE (1); FR (4); PA (1); IR (1)