Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD) | SCAI
Aug 1st 2020 | News & Clinical Trials

Transcatheter Aortic Valve Replacement to UNload the Left Ventricle in Patients With ADvanced Heart Failure (TAVR UNLOAD)

TAVR

A strategy trial for patients with moderate aortic stenosis, left ventricular dysfunction (EF 20- 50%) and heart failure symptoms.

TAVR UNLOAD is a strategy trial for patients with moderate aortic stenosis, left ventricular dysfunction (EF 20- 50%) and heart failure symptoms. Eligible patients will be randomized to immediate TAVR via a transfemoral approach versus clinical surveillance with deferred TAVR when the aortic stenosis becomes severe. Key inclusion criteria include BNP > 200 pg/mL (or NT-proBNP > 900 pg/mL) or a heart failure hospitalization within 2 years, stable guideline-directed medical therapy, and anatomy suitable for transfemoral TAVR with an Edwards Sapien device.  The study is planned for 300 subjects and anticipates completed enrollment by December 2021.  The primary outcomes are all-cause death, disabling stroke, hospitalizations for heart failure or valve disease, and change in KCCQ in 12-months.

All Editors: Jared M. O'Leary, MD