PARADIGM
PARADIGM: Amplatzer Valvular Plug for PVL Closure
AI Description
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.
- Who can join
- adult, older adult
- Participants
- 200
- Expected completion
- 2026-12-13
- Funded by
- industry
Conditions studied
Paravalvular Aortic Regurgitation
What is being tested
- DEVICE: AVP III
What it measures
- 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., 30 Days
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Abbott Northwestern Hospital
Minneapolis, MN
Baptist Memorial Hospital-Memphis
Memphis, TN
Carilion Roanoke Memorial Hospital
Roanoke, VA
Cleveland Clinic
Cleveland, OH
Emory University Hospital
Atlanta, GA
Hackensack University Medical Center
Hackensack, NJ
Intermountain Medical Center
Murray, UT
Lenox Hill Hospital
New York, NY
Massachusetts General Hospital
Boston, MA
Nebraska Medicine
Omaha, NE
NewYork-Presbyterian Hospital
New York, NY
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, WA
Saint Luke’s Hospital of Kansas City
Kansas City, MO
UAB Hospital
Birmingham, AL
Registry entry updated 2026-02-10
Deciding whether to join a study is your choice, and you can ask a study team questions before you decide anything.
If you would rather we did it with you, call us on (656) 206-4686.