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Alleviant ALLAY-HF Study
Recruiting
Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
Who can join
Ages 40 and older · All sexes
Full eligibility criteria
Inclusion Criteria:
1. Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
2. NYHA Class II, III or ambulatory IV
3. Exercise right heart catheterization\*
1. Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
2. Exercise PVR \< 1.8 WU
4. Ongoing stable GDMT
Exclusion Criteria:
1. Advanced heart failure
2. Presence of a pacemaker
3. Evidence of right heart dysfunction
About the study
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.
What is being tested
- Alleviant ALV1 System (device)
- Sham-Control (other)
Sponsor: Alleviant Medical, Inc. · Participants: 700 · Started: Jan 10, 2023
Contact the study team
Official record on ClinicalTrials.gov — NCT05685303
Locations in the U.S.
| Arizona | Pima Heart and Vascular, Tucson |
| California | Memorial Care Long Beach Medical Center, Long Beach
UC Davis Medical Center, Sacramento
Scripps Clinical Research Services, San Diego
University of California San Francisco, San Francisco
Santa Barbara Cottage Hospital, Santa Barbara |
| Florida | The Cardiac and Vascular Institute (TCAVI), Gainesville
HCA Florida Memorial Hospital, Jacksonville
NCH Research Institute, Naples
Advent Health Orlando, Orlando
Ascension Sacred Heart, Pensacola |
| Georgia | Atlanta VA Health Care System, Decatur |
| Illinois | Midwest Cardiovascular Institute, Naperville |
| Indiana | Indiana University, Indianapolis |
| Kentucky | St. Elizabeth Healthcare, Edgewood |
| Louisiana | Cardiovascular Institute of the South, Houma
University Medical Center New Orleans, New Orleans |
| Maryland | Johns Hopkins Medical Institution, Baltimore |
| Massachusetts | Boston Medical Center, Boston
Brigham and Women's Hospital, Boston |
| Michigan | VA Ann Arbor, Ann Arbor |
| Minnesota | Minneapolis Heart Institute Foundation, Minneapolis |
| Missouri | Washington University - St Louis, St Louis |
| Nevada | UMC of Southern Nevada, Las Vegas |
| New York | New York University, New York
Stony Brook Medicine, Stony Brook |
| North Carolina | Mission Hospital, Asheville
Duke University Hospital, Durham
NC Heart and Vascular Research, Raleigh |
| Ohio | Cleveland Clinic, Cleveland
ProMedica Toledo Hospital, Toledo |
| Oklahoma | South Oklahoma Heart Research, LLC., Oklahoma City |
| Pennsylvania | Pinnacle Health Cardiovascular Institute, Harrisburg |
| South Carolina | Medical University of South Carolina, Charleston
Prisma Health - Midlands, Colombia |
| South Dakota | Monument Health, Rapid City |
| Tennessee | Stern Cardiovascular Foundation, Germantown
Tennova Healthcare - Turkey Creek Medical Center, Knoxville |
| Texas | Hendrick Health, Abilene
Austin Heart, Austin
UT Southwestern, Dallas
Baylor Scott & White Research Institute, Plano
Waco Cardiology, Waco |
Conditions
From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.