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Recruiting Not applicable Interventional

Alleviant ALLAY-HF Study

ClinicalTrials.gov ID: NCT05685303

Public ClinicalTrials.gov record NCT05685303. 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 7, 2026, 5:34 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 System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure

Brief summary

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

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.

Study identification

NCT ID
NCT05685303
Recruitment status
Recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Alleviant Medical, Inc.
Industry
Enrollment
700 participants

Conditions and interventions

Conditions

Interventions

Device · Other

Eligibility (public fields only)

Age range
40 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
Jan 9, 2023
Primary completion
Nov 30, 2027
Completion
Nov 30, 2032
Last update posted
Aug 13, 2026

2023 – 2032

United States locations

U.S. sites
56
U.S. states
27
U.S. cities
53
Facility City State ZIP Site status
Arizona Cardiovascular Research Center Phoenix Arizona 85016 Active, not recruiting
HonorHealth Scottsdale Arizona 85258 Terminated
Pima Heart and Vascular Tucson Arizona 85718 Recruiting
Memorial Care Long Beach Medical Center Long Beach California 90806 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
Santa Barbara Cottage Hospital Santa Barbara California 93105 Recruiting
Hartford Hospital Hartford Connecticut 06106 Terminated
The Cardiac and Vascular Institute (TCAVI) Gainesville Florida 32504 Recruiting
HCA Florida Memorial Hospital Jacksonville Florida 32216 Recruiting
NCH Research Institute Naples Florida 34102 Recruiting
Advent Health Orlando Orlando Florida 32803 Recruiting
Ascension Sacred Heart Pensacola Florida 32504 Recruiting
Atlanta VA Health Care System Decatur Georgia 30032 Recruiting
Advocate Illinois Masonic Medical Center Chicago Illinois 60657 Terminated
Midwest Cardiovascular Institute Naperville Illinois 60540 Recruiting
Prairie Education and Research Cooperative Springfield Illinois 62769 Active, not recruiting
Indiana University Indianapolis Indiana 46202 Recruiting
St. Elizabeth Healthcare Edgewood Kentucky 41017 Recruiting
Cardiovascular Institute of the South Houma Louisiana 70360 Recruiting
University Medical Center New Orleans New Orleans Louisiana 70112 Recruiting
Johns Hopkins Medical Institution Baltimore Maryland 21287 Recruiting
Brigham and Women's Hospital Boston Massachusetts 02115 Recruiting
Boston Medical Center Boston Massachusetts 02118 Recruiting
Steward St. Elizabeth's Medical Center Brighton Massachusetts 02135 Terminated
VA Ann Arbor Ann Arbor Michigan 48105 Recruiting
Ascension St. John Hospital Detroit Michigan 48236 Terminated
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
VA NY Harbor Healthcare System New York New York 10010 Terminated
New York University New York New York 10016 Recruiting
Lenox Hill Hospital New York New York 10075 Active, not recruiting
St. Francis Hospital Roslyn New York 11576 Terminated
Stony Brook Medicine Stony Brook New York 11794-8167 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
South Oklahoma Heart Research, LLC. Oklahoma City Oklahoma 73135 Recruiting
Providence St. Vincent's Medical Center Portland Oregon 97225 Terminated
Pinnacle Health Cardiovascular Institute Harrisburg Pennsylvania 17101 Recruiting
Medical University of South Carolina Charleston South Carolina 29425 Recruiting
Prisma Health - Midlands Colombia South Carolina 29203 Recruiting
Monument Health Rapid City South Dakota 57701 Recruiting
Stern Cardiovascular Foundation Germantown Tennessee 38138 Recruiting
Tennova Healthcare - Turkey Creek Medical Center Knoxville Tennessee 37934 Recruiting
Hendrick Health Abilene Texas 79601 Recruiting
Austin Heart Austin Texas 78756 Recruiting
UT Southwestern Dallas Texas 75930 Recruiting
Baylor Scott & White Research Institute Plano Texas 75093 Recruiting
Waco Cardiology Waco Texas 76712 Recruiting
University of Washington Seattle Washington 98195 Active, not recruiting
Advocate Aurora Health/Aurora Research Institute Milwaukee Wisconsin 53215 Active, not 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 37 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05685303, 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 7, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT05685303 live on ClinicalTrials.gov.

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