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Enrolling by Invitation

NCT Number: NCT06812533

Alleviant ALLAY-HFrEF Study

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.

Enrolling by Invitation

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monash Health Victorian Heart Hospital, Clayton, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Alleviant ALV1 System

Device

Creation of interatrial shunt

sham-control

Other

Cardiac imaging

Primary outcomes

  1. Composite Primary Endpoint

    Time frame: 12-Month

    The primary endpoint is a composite of all-cause mortality or cardiac transplantation or permanent left ventricular assist device (LVAD) and heart failure events.

Sponsors and collaborators

Lead sponsor

Alleviant Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 6, 2025
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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