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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with perimembranous ventricular septal defects (PmVSDs) who provided informed consent and u |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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:
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study Principal Investigator | Contact | +33140942800 | raymondhaddad@live.com |
| Name | Affiliation | Role |
|---|---|---|
| Raymond N. Haddad, MD, MHSc | Marie Lannelongue Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Rigshospitalet | Copenhagen | Denmark | ||||
| University Hospital of Bordeaux |
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| From implant attempt to 12-month post-procedure |
|
| 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 |
| Bordeaux |
| France |
| Marie Lannelongue Hospital | Le Plessis-Robinson | France |
| Lille University Hospital | Lille | France |
| Toulouse University Hospital | Toulouse | France |
| University Children's Hospital | Tübingen | Germany |
| National Cardiovascular Center of Harapan Kita | Jakarta | Indonesia |
| Rajaie Cardiovascular, Medical and Research Center | Tehran | Iran |
| Hôtel-Dieu de France University Medical Center | Beirut | Lebanon |
| Hospital de Especialidades Pediátricas | Chiapas | Mexico |
| The Children's Hospital | Lahore | Pakistan |
| Silesian Center for Heart Diseases | Zabrze | Poland |
| Madinah Cardiac Center MCC | Madinah | Saudi Arabia |
| Ankara City Hospital | Ankara | Turkey (Türkiye) |
| Koç University | Istanbul | Turkey (Türkiye) |
| Umraniye Training and Education Hospital | Istanbul | Turkey (Türkiye) |
| SBU Tepecik Training and Research Hospital | Izmir | Turkey (Türkiye) |
| Al Jalila Children's Speciality Hospital | Dubai | United Arab Emirates |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D006330 | Heart Defects, Congenital |
| D006343 | Heart Septal Defects |
| D006345 | Heart Septal Defects, Ventricular |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006331 | Heart Diseases |
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