This study is accepting new patients by invitation only

Alleviant ALLAY-HF Study

a study on Heart Failure

Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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.

Official Title

Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure

Keywords

Heart Failure, Alleviant ALV1 System

Eligibility

You can join if…

Open to people ages 40 years and up

  1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
  2. NYHA Class II, III or ambulatory IV
  3. Exercise right heart catheterization*
    1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
    2. Exercise PVR < 1.8 WU
  4. Ongoing stable GDMT

You CAN'T join if...

  1. Advanced heart failure
  2. Presence of a pacemaker
  3. Evidence of right heart dysfunction

Locations

  • UCSF
    San Francisco California 94143 United States
  • San Francisco VA
    San Francisco California 94121 United States

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Alleviant Medical, Inc.
ID
NCT05685303
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated