Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction (EF) Heart Failure (Protocol #2201)
Sponsor: Corvia Medical
The primary objective of this randomized controlled clinical trial is to further evaluate the clinical efficacy of the Corvia Medical Interatrial Shunt Device system in symptomatic heart failure patients with a left ventricular ejection fraction of 40% or above, and elevated left sided filling pressures despite standard guideline directed medical therapy; and to confirm the treatment effect observed in the responder group of the REDUC-LAP-HF randomized trial.
Study team:
Project Manager: A. Branderhorst, M. Sietzema
Sub Investigator: J. Tiebesl