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Taking people in AustraliaNo phase

Creating a small heart opening without an implant for heart failure

Tests a no-implant heart shunt system in adults with heart failure.

Plain-language title generated from the registry record
Registry title: Alleviant ALLAY-HF Study

Key facts

Where
Clayton and Heidelberg, AustraliaSee the 2 sites

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with symptomatic heart failure and a pumping function (LVEF) of 40% or more. It tests a device that makes a small opening between the heart's upper chambers, compared with a sham procedure.

Age
40 years or older
Sex
All sexes can join
Disease stage
Symptomatic heart failure with LVEF 40% or more (HFpEF/HFmrEF); NYHA Class II, III or ambulatory IV; high left atrial pressure during exercise (25 mmHg or more) and exercise PVR below 1.8 WU on an exercise right heart catheterization
Earlier treatment
Stable, ongoing guideline-directed medical therapy (GDMT)
Biomarker or test result
Left atrial pressure of 25 mmHg or more during exercise right heart catheterization; exercise PVR below 1.8 WU

Main reasons for not taking part

  • Advanced heart failure
  • A pacemaker
  • Signs of right heart dysfunction

Read by machine on 12 November 2026.

Where in Australia

  • Monash Health Victorian Heart HospitalClayton, AustraliaContact: Robert Gooley, A/Prof (principal investigator)Taking people
  • Austin HospitalHeidelberg, AustraliaContact: Matias Yudi (principal investigator)Taking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Alleviant Medical, Inc.
Trial code
NCT05685303
Record updated
14 August 2026
Original description
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.Read full original descriptionShow less

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

Exclusion: Advanced heart failure; Evidence of right heart dysfunction; Presence of a pacemaker.

ClinicalTrials.gov NCT05685303