A pivotal trial of the Alleviant System for no-implant shunt creation in heart failure patients
A randomized, double-blinded, sham-controlled, adaptive trial to evaluate the safety and efficacy of the Alleviant System in patients with heart failure and who remain symptomatic despite medical therapy.
WHAT IS ALLAY-HF?
TRIAL DESIGN AND RATIONALE
To evaluate the clinical efficacy and safety of the Alleviant System to improve quality of life and reduce heart failure-related symptoms, hospitalizations and outpatient events in patients with heart failure.
PATIENT CRITERIA
Age 40+ who have symptomatic heart failure with exertional dyspnea
New York Heart Association Class II, III or ambulatory IV
Elevated PCWP during exercise