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Clinical Trial Summary

The Paradigm study is a prospective, multicenter, single arm study to demonstrate the safety and effectiveness of the 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.


Clinical Trial Description

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 PVLs occurring after aortic or mitral valve replacement with a surgically-implanted mechanical or bioprosthetic valve. The study will be conducted at up to 25 clinical sites in the US, EU and Canada, where 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 Design


Related Conditions & MeSH terms


NCT number NCT04489823
Study type Interventional
Source Abbott Medical Devices
Contact
Status Enrolling by invitation
Phase N/A
Start date December 1, 2020
Completion date June 30, 2026

See also
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Recruiting NCT05506293 - European Multicentre Registry of Percutaneous Paravalvular Leak Closure
Completed NCT05117359 - Transcatheter Para-Valvular Leak Closures