Amplatzer Plug for Aortic Regurgitation (PARADIGM Trial)
Trial Summary
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
The Amplatzer Vascular Plug III has been tested in laboratory settings for its ability to close leaks around heart valves, which suggests it might be effective in treating aortic regurgitation by sealing unwanted openings.
12345The Amplatzer Vascular Plug has been used safely in various procedures, such as preventing leaks during aneurysm repair and treating complications in dialysis access, indicating it is generally safe for human use.
13456The Amplatzer Valvular Plug III is unique because it is a self-expanding device designed to close leaks around heart valves, offering a minimally invasive option compared to traditional surgery. It is specifically used to address paravalvular leaks (gaps around a valve) and is deployed through a catheter, which is a thin tube inserted into the body, making it less invasive than open-heart surgery.
12578Eligibility Criteria
This trial is for adults over 18 with a mechanical or biological heart valve in the aortic or mitral position and significant paravalvular leak causing heart issues or needing blood transfusions. Not eligible if pregnant, nursing, have limited life expectancy, unstable health, other conflicting conditions, or are in another drug/device study.Inclusion Criteria
Exclusion Criteria
Participant Groups
- Closure of paravalvular leaks (PVLs) following surgical implant of a mechanical or biological heart valve implanted in the aortic or mitral position
- Closure of paravalvular leaks (PVLs) following surgical implant of a mechanical or biological heart valve implanted in the aortic or mitral position