ClinicalTrials.gov record
Enrolling by invitation 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.

ClinicalTrials.gov public records Last synced May 16, 2026, 2:40 PM 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

Study identification

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

Conditions and interventions

Conditions

Interventions

  • Alleviant ALV1 System Device
  • Sham-Control Other

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
Apr 20, 2026

2025 – 2028

United States locations

U.S. sites
32
U.S. states
17
U.S. cities
28
Facility City State ZIP Site status
Keck Medical Center of USC Los Angeles California 90033
UC Davis Medical Center Sacramento California 95817
Scripps Clinical Research Services San Diego California 92121
University of California San Francisco San Francisco California 94143
Ascension Sacred Heart Pensacola Florida 32504
Atlanta VA Health Care System Decatur Georgia 30032
Midwest Cardiovascular Institute Naperville Illinois 60540
Cardiovascular Institute of the South Houma Louisiana 70360
University Medical Center New Orleans New Orleans Louisiana 70112
Tufts Medical Center Boston Massachusetts 02111
Brigham and Women's Hospital Boston Massachusetts 02115
Boston Medical Center Boston Massachusetts 02118
Minneapolis Heart Institute Foundation Minneapolis Minnesota 55407
Washington University - St Louis St Louis Missouri 63110
Stony Brook Medicine New York New York 11794
Rochester General Hospital Rochester New York 14621
Mission Hospital Asheville North Carolina 28801
Duke University Hospital Durham North Carolina 27705
NC Heart and Vascular Research Raleigh North Carolina 27607
Cleveland Clinic Cleveland Ohio 44195
ProMedica Toledo Hospital Toledo Ohio 43606
Pinnacle Health Cardiovascular Institute Harrisburg Pennsylvania 17101
Roper St. Francis Healthcare Charleston South Carolina 29414
Medical University of South Carolina Charleston South Carolina 29425
Monument Health Rapid City South Dakota 57701
Tennova Healthcare - Turkey Creek Medical Center Knoxville Tennessee 37934
Hendrick Health Abilene Texas 79601
Texas Cardiac Arrhythmia Research Foundation Austin Texas 78705
Austin Heart Austin Texas 78756
Baylor Scott & White Research Institute Plano Texas 75093
NextStage Clinical Research Waco Texas 76712
Carilion Clinic Roanoke Virginia 24014

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 26 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 Apr 20, 2026 · Synced May 16, 2026

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Open the official record

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

View official ClinicalTrials.gov record →