Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.
Inclusion Criteria:
Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
NYHA Class II, III or ambulatory IV
Exercise right heart catheterization*
Ongoing stable GDMT
Exclusion Criteria:
jen.olson@alleviantmedical.com+1 612 327 2741
Springfield, Illinois 62769, United States
Colombia, South Carolina 29203, United States
Milwaukee, Wisconsin 53215, United States
Montreal, Quebec H2X 0C1, Canada
Zrifin, Israel