An interventional study of AVP III in Paravalvular Aortic Regurgitation, sponsored by Abbott Medical Devices. Active, not recruiting at 24 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment
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.
Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.
Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Includes all eligible subjects who undergo an AVP III implant attempt for treatment of significant paravalvular leakage with an echocardiographic severity grade of moderate or higher. This is a single arm study.
Device: AVP III
Transcatheter closure of a paravalvular leak using AVP III
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
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Abbott Medical Devices