The JenaValve ALIGN-AR LVAD Registry
At a glance
Conditions
Where it's being run
14 sites across 11 statesStudy leadership
- Nir Uriel, MD · STUDY_CHAIR · Columbia University
- Vinod Thourani, MD · PRINCIPAL_INVESTIGATOR · Piedmont Heart Institute
- Ravi Ramana, DO · PRINCIPAL_INVESTIGATOR · advocate christ medical center
- Gabriel Sayer, MD · PRINCIPAL_INVESTIGATOR · Columbia University
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Device Success30 days
Freedom from unsuccessful delivery of the device, and retrieval of the delivery system
- Device Positioning30 days
Freedom from incorrect positioning of a single prosthetic heart valve into the proper anatomical location
- Device Performance30 days
Intended performance of the valve (i.e., no moderate or severe prosthetic valve regurgitation)\*
- Surgery/intervention related to device30 days
Freedom from surgery or intervention related to the device# or to a major vascular or access-related or cardiac structural complication
- Bleeding30 days
Freedom from VARC type 2-4 bleeding
- All Stroke30 days
Number of patients that had stroke
- Acute Kidney Injury30 days
Number of patients that had acute kidney injury (AKI) stage 3 or 4
- Total aortic regurgitation30 days
Number of patients that had moderate or severe total aortic regurgitation
- Major Vascular Complication30 days
Number of patients that had major vascular, access-related, or cardiac structural complication
- Permanent pacemaker implantation30 days
Number of patients that had these events
- All-cause mortality30 days
All-cause mortality within the first 30 days post index procedure