TAVR UNLOAD Study

Condition: Aortic stenosis, heart failure, aortic insufficiency

Eligibility

Key Inclusion Criteria

  • New York Heart Association Class ≥2
  • NT-proBNP >1500 pg/mL (or BNP >400 pg/mL) or hospitalization for heart failure within the last year
  • Under appropriate guideline-directed heart failure therapy for a minimum of three months

Key Exclusion Criteria

  • Left ventricular ejection fraction <20% or persistent need for intravenous inotropic support
  • Hospitalization for acute decompensated heart failure within two weeks before assignment to treatment group
  • Cardiac resynchronization therapy device implantation within three months before assignment to treatment group

Full Study Name

Transcatheter Aortic Valve Replacement to Unload the Left Ventricle in Patients With Advanced Heart Failure: A Randomized Trial (TAVR UNLOAD) (IRB no. 44535)

Summary

This study focuses on patients with heart failure (HF) who have moderate aortic stenosis (AS). The purpose of the study is to compare the safety and effectiveness of transcatheter aortic valve replacement (TAVR) with the Edwards SAPIEN 3 transcatheter heart valve (THV) and optimal heart failure therapy (OHFT) versus OHFT alone in HF patients with moderate AS. OHFT is defined as guideline-directed medical therapy (medication only or a combination of medical therapy and approved heart failure devices).

TAVR is a method that has been successfully used to replace aortic valves; the procedure allows for replacement of the aortic valve with a biological tissue valve in a minimally invasive manner without the need for open-heart surgery. The Edwards SAPIEN 3 is approved by the U.S. Food and Drug Administration (FDA) for severe aortic stenosis. However, it is not approved by the FDA for treatment of heart failure in patients with moderate aortic stenosis.

Phase

Phase III


Principal Investigator

Raj Makkar, MD

Contact