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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Perimembranous Ventricular Septal Defect
• Intervention / Treatment: Device: Transcatheter device closure of perimembranous ventricular septal defects (PmVSDs)

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Study Principal Investigator; Phone Number: +33140942800; Email: raymondhaddad@live.com

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Copenhagen University Hospital, Rigshospitalet
• France
  • Bordeaux, France
    • University Hospital of Bordeaux
  • Le Plessis-Robinson, France
    • Marie Lannelongue Hospital
  • Lille, France
    • Lille University Hospital
  • Toulouse, France
    • Toulouse University Hospital
• Germany
  • Tuebingen, Germany
    • University Children's Hospital
• Indonesia
  • Jakarta, Indonesia
    • National Cardiovascular Center of Harapan Kita
• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Rajaie Cardiovascular, Medical and Research Center
• Lebanon
  • Beirut, Lebanon
    • Hôtel-Dieu de France University Medical Center
• Mexico
  • Chiapas, Mexico
    • Hospital de Especialidades Pediátricas
• Pakistan
  • Lahore, Pakistan
    • The Children's Hospital
• Poland
  • Zabrze, Poland
    • Silesian Center for Heart Diseases
• Saudi Arabia
  • Madinah, Saudi Arabia
    • Madinah Cardiac Center MCC
• Turkey
  • Ankara, Turkey
    • Ankara City Hospital
  • Istanbul, Turkey
    • Koc University
  • Istanbul, Turkey
    • Ümraniye Training and Education hospital
  • Izmir, Turkey
    • SBU Tepecik Training and Research Hospital
• United Arab Emirates
  • Dubai, United Arab Emirates
    • Al Jalila Children's Speciality Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with perimembranous ventricular septal defects (PmVSDs) who provided informed consent and u	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short-term complications (≤30 days)	Minor vascular complications (hematoma, pseudoaneurysm, minor bleeding). Transient arrhythmias (supraventricular tachycardia, non-sustained VT, first-degree AV block).	From implant attempt to 30 days post-procedure
Long-term outcomes	Sustained complete closure (no or minimal residual shunt on TTE).; Late-onset device-related complications (new-onset aortic or tricuspid regurgitation, delayed second-degree or complete heart block, or arrhythmias requiring permanent treatment).; Device migration or embolization requiring catheter or surgical removal; Thromboembolism: thrombosis of device or vascular access that requires thrombolytic therapy; Hemolysis requiring prolonged or redo hospitalization and severe acute hemolysis requiring blood transfusion with or without intervention.; Death	From implant attempt to 60-month post-procedure
Rate of incomplete closure at the 24-month follow-up.	Rate of incomplete closure at the 24-month follow-up: A significant shunt will be defined as ≥ moderate or requiring treatment (surgical or interventional). The residual shunt will be assessed using color Doppler echocardiography, with shunt size categorized according to previously published classifications.	From implant attempt to 24-month post-procedure
Functional and quality-of-life measures	Improvement in NYHA/ROSS functional class and in pediatric patients, catch-up growth.	From implant attempt to 48-month post-procedure

Collaborators and Investigators

• Sponsor: Fondation Hôpital Saint-Joseph
• Investigators: Principal Investigator: Raymond N. Haddad, MD, MHSc, Marie Lannelongue Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: January 31, 2025
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Heart Defects, Congenital; Cardiovascular Abnormalities; Heart Septal Defects, Ventricular; Device Closure; Heart Septal Defects; Transcatheter Interventions; Ventricular Septal Defects
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Defects, Congenital; Heart Septal Defects; Heart Septal Defects, Ventricular
• Other Study ID Numbers: PERI-CLOSE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No