Alleviant ALLAY-HFrEF Study

NCT06812533 · tracked via the Priya Life Science USA tracker

Sponsor

Alleviant Medical, Inc.

Phase

Not applicable

Started

2025-03-10

Last updated

2026-09-16

Condition(s) studied

Heart Failure

Investigational drug(s) / intervention(s)

Alleviant ALV1 SystemSham-Control

Alleviant ALV1 System: Creation of interatrial shunt

Sham-Control: Cardiac imaging

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

Composite Primary Endpoint — 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.

Trial sites (68)

Facility	City	Region	Status
Keck Medical Center of USC	Los Angeles	California	Recruiting
University California Los Angeles Medical Center	Los Angeles	California	Recruiting
UC Davis Medical Center	Sacramento	California	Recruiting
Scripps Clinical Research Services	San Diego	California	Recruiting
University of California San Francisco	San Francisco	California	Recruiting
Delray Medical Center	Delray Beach	Florida	Recruiting
Ascension Sacred Heart	Pensacola	Florida	Recruiting
Tampa General Hospital	Tampa	Florida	Recruiting
Atlanta VA Health Care System	Decatur	Georgia	Recruiting
Midwest Cardiovascular Institute	Naperville	Illinois	Recruiting
Cardiovascular Institute of the South	Houma	Louisiana	Recruiting
University Medical Center New Orleans	New Orleans	Louisiana	Recruiting
Tufts Medical Center	Boston	Massachusetts	Recruiting
Brigham and Women's Hospital	Boston	Massachusetts	Recruiting
Boston Medical Center	Boston	Massachusetts	Recruiting
Minneapolis Heart Institute Foundation	Minneapolis	Minnesota	Recruiting
Washington University - St Louis	St Louis	Missouri	Recruiting
UMC of Southern Nevada	Las Vegas	Nevada	Recruiting
Deborah Heart & Lung Center	Browns Mills	New Jersey	Recruiting
Englewood Medical Center	Englewood	New Jersey	Recruiting
Stony Brook Medicine	New York	New York	Recruiting
Rochester General Hospital	Rochester	New York	Recruiting
University of Rochester Medical Center	Rochester	New York	Not Yet Recruiting
Mission Hospital	Asheville	North Carolina	Recruiting
Duke University Hospital	Durham	North Carolina	Recruiting
NC Heart and Vascular Research	Raleigh	North Carolina	Recruiting
Cleveland Clinic	Cleveland	Ohio	Recruiting
ProMedica Toledo Hospital	Toledo	Ohio	Recruiting
Pinnacle Health Cardiovascular Institute	Harrisburg	Pennsylvania	Recruiting
Roper St. Francis Healthcare	Charleston	South Carolina	Recruiting
Medical University of South Carolina	Charleston	South Carolina	Recruiting
Monument Health	Rapid City	South Dakota	Recruiting
Tennova Healthcare - Turkey Creek Medical Center	Knoxville	Tennessee	Recruiting
Hendrick Health	Abilene	Texas	Recruiting
Texas Cardiac Arrhythmia Research Foundation	Austin	Texas	Terminated
Austin Heart	Austin	Texas	Recruiting
Baylor Scott & White Research Institute	Plano	Texas	Recruiting
Baylor Scott & White - Temple	Temple	Texas	Recruiting
Waco Cardiology	Waco	Texas	Recruiting
Carilion Clinic	Roanoke	Virginia	Recruiting

+ 28 more sites — see the full list on the official registry below.

More Alleviant Medical, Inc. trials in the USA

Alleviant ALLAY-HF Study Recruiting

Other trials for the same condition

ALT-FLOW II Trial of the Edwards APTURE Transcatheter Shunt System Active, not recruiting

A Study of LY3971297 in Participants With Heart Failure Recruiting

Ultra-High Frequency - Electrocardiogram (UHF-ECG) for the Diagnosis of Ventricular Electrical Dyssynchrony (VED) Recruiting

A Multi-center, National, Open-label, Prospective Study to Evaluate the Performance of the V-Lap™ System Recruiting

Cardiac Resynchronization Therapy in Previously Untreatable and High Risk Upgrade Patients Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06812533 on ClinicalTrials.gov ↗ ← All trials in the USA