Re-Evaluation of the Corvia Atrial Shunt Device in a PrecisiON Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved EF Heart Failure
Sponsor: Corvia
The primary objective of this clinical trial is to further evaluate the clinical efficacy of the Corvia Atrial Shunt in symptomatic heart failure patients with a left ventricular ejection fraction (LVEF) ≥ 40%, and elevated left sided filling pressures despite standard Guideline-Directed Medical Therapy (GDMT); and to confirm the treatment effect observed in the responder group of the REDUCE LAP-HF Randomized Trial II.
Study team:
– PI: Dr. E.S. Hoendermis
– Sub-investigators: Dr. T.M. Gorter
– Project coordinators: M. Sietzema