The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the Amplatzer Valvular Plug III (AVP III) as a treatment for clinically significant PVLs following surgical implant of a mechanical or biological heart valve implanted in the aortic or mitral position.
PARADIGM is a prospective, international, multi-center, single arm study to demonstrate the safety and effectiveness of the AVP III for percutaneous, transcatheter closure of paravalvular leak (PVL) occurring after aortic or mitral valve replacement with a surgically-implanted mechanical or bioprosthetic valve. The study will be conducted at approximately 25 clinical sites in the US, Europe, and Canada. A total of 200 subjects with a clinically significant PVL will undergo an AVP III implant procedure for PVL closure. Pre-procedural Baseline and follow-up assessments at Discharge, 30 days, 6 months and 1 year will include echocardiography, physical examinations, lab measurements and questionnaires to assess PVL severity, prosthetic valve function, hemolytic anemia, heart failure symptoms, and quality of life. Adverse events will be recorded throughout the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Transcatheter closure of a paravalvular leak using AVP III
University Hospital - Univ. of Alabama at Birmingham (UAB)
Birmingham, Alabama, United States
Paravalvular leak closure success rate (percent of subjects)
* Successful transcatheter placement in the intended location without interference * Reduction in paravalvular regurgitation severity by ≥ two grades * Freedom from intra-procedural death * Freedom from unplanned transcatheter or surgical re-intervention through 30 days post-implant.
Time frame: 30 Days
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