Healthcare Professionals

allay-hf

Clinical trial

Study Overview

A randomized, double-blinded, sham-controlled, adaptive trial to evaluate the safety and efficacy of the Alleviant System in patients with heart failure with preserved ejection fraction (HFpEF).

Study design

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 HFpEF.

Study Population

  • 400-700 randomized (1:1) participants
  • Age > 40 years
  • HFpEF (EF ≥ 40%)

Alleviant System (Treatment)

Sham Control

Primary Composite Endpoint

  • Cardiovascular-related death
  • Heart failure events
  • Kansas City Cardiomyopathy Questionnaire (KCCQ)

Visit www.clinicaltrials.gov (NCT05685303) for additional trial information.

Who should be considered?

Patients who have symptomatic HF or unexplained dyspnea may be candidates for ALLAY-HF.

Key inclusion Criteria:

01

Age ≥ 40 years

02

LVEF ≥ 40%

03

New York Heart Association Class II, III or ambulatory IV

04

Elevated PCWP during exercise