IRB Study Number 21-1002
Status Recruiting
Phase Not Applicable
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
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.
Inclusion Criteria
- Subject is implanted with a mechanical or biological surgical valve in the aortic or mitral position
- Subject has a clinically significant paravalvular leak with a severity grade of moderate or higher, associated with signs of heart failure and/or hemolysis necessitating recurring blood transfusions
- Subject has one PVL defect that can be closed with a single AVP III as assessed pre-procedurally
- Other Inclusion Criteria will be assessed by study personnel
Exclusion Criteria
- Subject has a rocking valve or extreme dehiscence of the prosthetic valve
- Subject who is hemodynamically unstable or who cannot undergo an elective procedure
- Subject with known or suspected active endocarditis or other active infection
- Other Exclusion Criteria will be assessed by study personnel.
