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Clinical Trials in Poland / NCT06812533
Recruiting Not applicable

Alleviant ALLAY-HFrEF Study

NCT06812533 · tracked via the Priya Life Science Poland tracker
Sponsor
Alleviant Medical, Inc
Phase
Not applicable
Started
2025-03-10
Last updated
2026-10-06

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
No
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 (70)

FacilityCityRegionStatus
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 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

+ 30 more sites — see the full list on the official registry below.

More Alleviant Medical, Inc. trials in Poland

Alleviant ALLAY-HF Study Recruiting

Other trials for the same condition

Evaluation of Liver Stiffness Performance, by FibroScan®, to Detect Elevated Central Venous Pressure (CVP) Recruiting
Nationwide Registry of Patients With Heart Failure With Improved and Supranormal Ejection Fraction Active, not recruiting
A Study on Remote Health Support for Patients With Heart Failure. Starting soon
A Research Study Comparing CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Reduced/Mildly Reduced Ejection Fraction and Left Ventricular Hypertrophy Recruiting
A Research Study Comparing Different Doses of CDR132L With Placebo on the Structure and Function of the Heart in People With Heart Failure With Preserved Ejection Fraction and Left Ventricular Hypertrophy 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 Poland