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.

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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

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

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Stacia Kraus

CONTACT

[email protected]

612-387-4552

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: Aug 14, 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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Recruiting