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.
Study Type
OBSERVATIONAL
Enrollment
1,000
Transcatheter closure of perimembranous ventricular septal defects (PmVSDs) using an occluder device either specifically designed for this purpose or used off-label.
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
University Hospital of Bordeaux
Bordeaux, France
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).
Time frame: From implant attempt to 12 hours post-procedure
Technical success
Successful device deployment and stable device position confirmed via post-procedure transthoracic echocardiography (TTE).
Time frame: From implant attempt to 12 hours post-procedure
Closure success
Complete shunt occlusion or trivial shunt on post-procedure TTE
Time frame: 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.
Time frame: 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.
Time frame: 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.
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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
...and 8 more locations
Time frame: From implant attempt to 12-month post-procedure
Short-term complications (≤30 days)
Minor vascular complications (hematoma, pseudoaneurysm, minor bleeding). Transient arrhythmias (supraventricular tachycardia, non-sustained VT, first-degree AV block).
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: From implant attempt to 48-month post-procedure