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AMPLATZER Membranous VSD Occluder · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| AMPLATZER Membranous VSD Occluder | DEVICE | Device closure with the AMPLATZER Membranous VSD Occluder |
Inclusion Criteria: * Patients with hemodynamically significant Perimembranous ventricular septal defects Exclusion Criteria: * Patients \< 8 kg * Supracristal ventricular septal defects * Left ventricle to right atrium shunting * Prolapse of the aortic valve * Right to left shunting through the ...
The AMPLATZER Membranous VSD Occluder is a device used for closing membranous ventricular septal defects, which are congenital heart defects characterized by an abnormal opening in the wall separating the heart's lower chambers. It is designed to occlude or block this defect to restore normal blood flow.
The AMPLATZER Membranous VSD Occluder is developed by Abbott Laboratories, a company traded on the New York Stock Exchange under the ticker symbol ABT. Abbott is a global healthcare company that produces medical devices, diagnostics, and pharmaceuticals.
The AMPLATZER Membranous VSD Occluder is in Phase 1 of clinical development. It is an investigational device, meaning it has not yet been approved for general use and is still undergoing clinical evaluation to assess its safety and effectiveness in treating membranous ventricular septal defects.
The AMPLATZER Membranous VSD Occluder has one completed clinical trial, identified by the National Clinical Trial number NCT00578708. This trial, titled 'Closure of Perimembranous Ventricular Septal Defects With The AMPLATZER® Membranous VSD OCCLUDER,' was conducted in the United States and enrolled 35 participants.
The AMPLATZER Membranous VSD Occluder is not FDA approved. It is an investigational device currently in Phase 1 clinical development. The completed trial NCT00578708 evaluated its use in 35 patients with membranous ventricular septal defects, but the device has not yet received regulatory approval for commercial use.