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

Not yet recruiting

• Conditions: Perimembranous Ventricular Septal Defect

• Registration Number: NCT06823635
• Lead Sponsor: Fondation Hôpital Saint-Joseph

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).

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 Timeline

• Study First Submitted: 2025-01-31
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-07
• Last Update Submitted: 2025-02-07
• Study First Posted: 2025-02-12
• Last Update Posted: 2025-02-12
• Study Start: 2025-03-01
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Twelve-month composite non-hierarchical clinical success	From implant attempt to 12 hours post-procedure	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).
Closure success	From implant attempt to 12 hours post-procedure	Complete shunt occlusion or trivial shunt on post-procedure TTE
Procedural success	From implant attempt to 12 hours post-procedure	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.
Technical success	From implant attempt to 12 hours post-procedure	Successful device deployment and stable device position confirmed via post-procedure transthoracic echocardiography (TTE).
Clinical success	From implant attempt to 12-month post-procedure	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.
Freedom from procedure or device-related major adverse events	From implant attempt to 12-month post-procedure	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.

Secondary Outcome Measures

Name	Time	Method
Short-term complications (≤30 days)	From implant attempt to 30 days post-procedure	Minor vascular complications (hematoma, pseudoaneurysm, minor bleeding). Transient arrhythmias (supraventricular tachycardia, non-sustained VT, first-degree AV block).
Rate of incomplete closure at the 24-month follow-up.	From implant attempt to 24-month post-procedure	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.
Functional and quality-of-life measures	From implant attempt to 48-month post-procedure	Improvement in NYHA/ROSS functional class and in pediatric patients, catch-up growth.
Long-term outcomes	From implant attempt to 60-month post-procedure	* 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

Trial Locations

Locations (18)

Copenhagen University Hospital, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

University Hospital of Bordeaux; 🇫🇷 Bordeaux, France

Marie Lannelongue Hospital; 🇫🇷 Le Plessis-Robinson, France

Lille University Hospital; 🇫🇷 Lille, France

Toulouse University Hospital; 🇫🇷 Toulouse, France

Hospital de Especialidades Pediátricas; 🇲🇽 Chiapas, Mexico

Madinah Cardiac Center MCC; 🇸🇦 Madinah, Saudi Arabia

University Children's Hospital; 🇩🇪 Tuebingen, Germany

Ankara City Hospital; 🇹🇷 Ankara, Turkey

Al Jalila Children's Speciality Hospital; 🇦🇪 Dubai, United Arab Emirates

National Cardiovascular Center of Harapan Kita; 🇮🇩 Jakarta, Indonesia

Koç University; 🇹🇷 Istanbul, Turkey

Rajaie Cardiovascular, Medical and Research Center; 🇮🇷 Tehran, Iran, Islamic Republic of

Hôtel-Dieu de France University Medical Center; 🇱🇧 Beirut, Lebanon

The Children's Hospital; 🇵🇰 Lahore, Pakistan

SBU Tepecik Training and Research Hospital; 🇹🇷 Izmir, Turkey

Silesian Center for Heart Diseases; 🇵🇱 Zabrze, Poland

Umraniye Training and Education Hospital; 🇹🇷 Istanbul, Turkey