JENA-VAD
The JenaValve ALIGN-AR LVAD Registry
AI Description
To evaluate the safety and effectiveness of the JenaValve Trilogy™ Heart Valve System for transcatheter aortic valve replacement (TAVR) in subjects with continuous flow left ventricular assist devices (cfLVAD) and clinically significant aortic regurgitation (AR) who are indicated for TAVR
- Who can join
- adult, older adult
- Participants
- 50
- Expected completion
- 2027-08
- Funded by
- industry
Conditions studied
Aortic Insufficiency, Aortic Regurgitation, Aortic Valve Disease, Aortic Valve Insufficiency, Left Ventricular Dysfunction
What is being tested
- DEVICE: JenaValve Trilogy Heart Valve System
What it measures
- Acute Kidney Injury, Number of patients that had acute kidney injury (AKI) stage 3 or 4, 30 days
- All Stroke, Number of patients that had stroke, 30 days
- All-cause mortality, All-cause mortality within the first 30 days post index procedure, 30 days
- Bleeding, Freedom from VARC type 2-4 bleeding, 30 days
- Device Performance, Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)\*, 30 days
- Device Positioning, Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location, 30 days
- Device Success, Freedom from unsuccessful delivery of the device, and retrieval of the delivery system, 30 days
- Major Vascular Complication, Number of patients that had major vascular, access-related, or cardiac structural complication, 30 days
- Permanent pacemaker implantation, Number of patients that had these events, 30 days
- Surgery/intervention related to device, Freedom from surgery or intervention related to the device# or to a major vascular or access-related or cardiac structural complication, 30 days
- Total aortic regurgitation, Number of patients that had moderate or severe total aortic regurgitation, 30 days
Centers Participating
These centers are participating in this study. Reach out to them directly to learn more.
Abbott Northwestern Hospital
Minneapolis, MN
Advocate Christ Medical Center (Oak Lawn)
Oak Lawn, IL
Barnes-Jewish Hospital
Saint Louis, MO
Baylor Scott & White The Heart Hospital – Plano
Plano, TX
California Pacific Medical Center (Van Ness Campus)
San Francisco, CA
Cedars-Sinai Medical Center
Los Angeles, CA
Henry Ford Health (Detroit)
Detroit, MI
Houston Methodist Hospital
Houston, TX
Intermountain Medical Center
Murray, UT
MedStar Washington Hospital Center
Washington, DC
Piedmont Atlanta Hospital
Atlanta, GA
Sentara Norfolk General Hospital
Norfolk, VA
University of Michigan Health System
Ann Arbor, MI
Registry entry updated 2026-07-22
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.