This study is accepting new patients by invitation only

Alleviant ALLAY-HFrEF Study

a study on Heart Failure

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around

Description

Summary

Prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFrEF.

Official Title

Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction

Keywords

Heart Failure, Alleviant ALV1 System

Eligibility

You can join if…

Open to people ages 18 years and up

  • LVEF ≤ 40%
  • NYHA class II, III or ambulatory IV HF
  • Receiving optimal, maximally tolerated, stable GDMT

You CAN'T join if...

  • Advanced heart failure
  • Life-expectancy < 12 months
  • Evidence of right heart dysfunction

Locations

  • UCSF
    San Francisco California 94143 United States
  • Monument Health
    Rapid City South Dakota 57701 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Alleviant Medical, Inc.
ID
NCT06812533
Study Type
Interventional
Participants
Expecting 350 study participants
Last Updated