Alleviant ALLAY-HFrEF Study
NCT06812533
This study is recruiting at 39 US sites in 19 states, according to its ClinicalTrials.gov record last updated .
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Heart Failure
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Not applicable
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Alleviant Medical, Inc.
- Last updated on ClinicalTrials.gov
- October 6, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 5
- Keck Medical Center of USC · Los Angeles, CA
- University California Los Angeles Medical Center · Los Angeles, CA
- UC Davis Medical Center · Sacramento, CA
- Scripps Clinical Research Services · San Diego, CA
- University of California San Francisco · San Francisco, CA
Florida · 3
- Delray Medical Center · Delray Beach, FL
- Ascension Sacred Heart · Pensacola, FL
- Tampa General Hospital · Tampa, FL
Georgia · 1
- Atlanta VA Health Care System · Decatur, GA
Illinois · 1
- Midwest Cardiovascular Institute · Naperville, IL
Louisiana · 2
- Cardiovascular Institute of the South · Houma, LA
- University Medical Center New Orleans · New Orleans, LA
Massachusetts · 3
- Boston Medical Center · Boston, MA
- Brigham and Women's Hospital · Boston, MA
- Tufts Medical Center · Boston, MA
Minnesota · 1
- Minneapolis Heart Institute Foundation · Minneapolis, MN
Missouri · 1
- Washington University - St Louis · St Louis, MO
Nevada · 1
- UMC of Southern Nevada · Las Vegas, NV
New Jersey · 2
- Deborah Heart & Lung Center · Browns Mills, NJ
- Englewood Medical Center · Englewood, NJ
New York · 3
- Stony Brook Medicine · New York, NY
- Rochester General Hospital · Rochester, NY
- University of Rochester Medical Center · Rochester, NY
North Carolina · 3
- Mission Hospital · Asheville, NC
- Duke University Hospital · Durham, NC
- NC Heart and Vascular Research · Raleigh, NC
Ohio · 2
- Cleveland Clinic · Cleveland, OH
- ProMedica Toledo Hospital · Toledo, OH
Pennsylvania · 1
- Pinnacle Health Cardiovascular Institute · Harrisburg, PA
South Carolina · 2
- Medical University of South Carolina · Charleston, SC
- Roper St. Francis Healthcare · Charleston, SC
South Dakota · 1
- Monument Health · Rapid City, SD
Tennessee · 1
- Tennova Healthcare - Turkey Creek Medical Center · Knoxville, TN
Texas · 5
- Hendrick Health · Abilene, TX
- Austin Heart · Austin, TX
- Baylor Scott & White Research Institute · Plano, TX
- Baylor Scott & White - Temple · Temple, TX
- Waco Cardiology · Waco, TX
Virginia · 1
- Carilion Clinic · Roanoke, VA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.