Alleviant ALLAY-HF Study

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

40 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

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 criteria

Advanced heart failure
Presence of a pacemaker
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 mortality, heart failure events and quality of life based on Kansas City Cardiomyopathy Questionnaire (KCCQ) calculated at 12 months. KCCQ responses are provided along a rating scale from 0-100 with a higher score indicating better health.

Sponsors and collaborators

Lead sponsor

Alleviant Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2027
Study completion: 2032
First posted: Jan 17, 2023
Registry last updated: May 4, 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.

Published trials that share one or more normalized conditions with this study.

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