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Recruiting Not applicable Interventional

Alleviant ALLAY-HFrEF Study

ClinicalTrials.gov ID: NCT06812533

Public ClinicalTrials.gov record NCT06812533. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 6, 2026, 4:41 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06812533
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Alleviant Medical, Inc.
Industry
Enrollment
350 participants

Conditions and interventions

Conditions

Interventions

Device · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 9, 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2028
Last update posted
Aug 13, 2026

2025 – 2028

United States locations

U.S. sites
39
U.S. states
19
U.S. cities
34
Facility City State ZIP Site status
Keck Medical Center of USC Los Angeles California 90033 Recruiting
University California Los Angeles Medical Center Los Angeles California 90095 Recruiting
UC Davis Medical Center Sacramento California 95817 Recruiting
Scripps Clinical Research Services San Diego California 92121 Recruiting
University of California San Francisco San Francisco California 94143 Recruiting
Delray Medical Center Delray Beach Florida 33484 Recruiting
Ascension Sacred Heart Pensacola Florida 32504 Recruiting
Tampa General Hospital Tampa Florida 33606 Recruiting
Atlanta VA Health Care System Decatur Georgia 30032 Recruiting
Midwest Cardiovascular Institute Naperville Illinois 60540 Recruiting
Cardiovascular Institute of the South Houma Louisiana 70360 Recruiting
University Medical Center New Orleans New Orleans Louisiana 70112 Recruiting
Tufts Medical Center Boston Massachusetts 02111 Recruiting
Brigham and Women's Hospital Boston Massachusetts 02115 Recruiting
Boston Medical Center Boston Massachusetts 02118 Recruiting
Minneapolis Heart Institute Foundation Minneapolis Minnesota 55407 Recruiting
Washington University - St Louis St Louis Missouri 63110 Recruiting
UMC of Southern Nevada Las Vegas Nevada 89102 Recruiting
Deborah Heart & Lung Center Browns Mills New Jersey 08015 Recruiting
Englewood Medical Center Englewood New Jersey 07631 Recruiting
Stony Brook Medicine New York New York 11794 Recruiting
Rochester General Hospital Rochester New York 14621 Recruiting
Mission Hospital Asheville North Carolina 28801 Recruiting
Duke University Hospital Durham North Carolina 27705 Recruiting
NC Heart and Vascular Research Raleigh North Carolina 27607 Recruiting
Cleveland Clinic Cleveland Ohio 44195 Recruiting
ProMedica Toledo Hospital Toledo Ohio 43606 Recruiting
Pinnacle Health Cardiovascular Institute Harrisburg Pennsylvania 17101 Recruiting
Roper St. Francis Healthcare Charleston South Carolina 29414 Recruiting
Medical University of South Carolina Charleston South Carolina 29425 Recruiting
Monument Health Rapid City South Dakota 57701 Recruiting
Tennova Healthcare - Turkey Creek Medical Center Knoxville Tennessee 37934 Recruiting
Hendrick Health Abilene Texas 79601 Recruiting
Texas Cardiac Arrhythmia Research Foundation Austin Texas 78705 Recruiting
Austin Heart Austin Texas 78756 Recruiting
Baylor Scott & White Research Institute Plano Texas 75093 Recruiting
Baylor Scott & White - Temple Temple Texas 76508 Recruiting
Waco Cardiology Waco Texas 76712 Recruiting
Carilion Clinic Roanoke Virginia 24014 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 28 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06812533, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 13, 2026 · Synced Sep 6, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06812533 live on ClinicalTrials.gov.

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