Alleviant ALLAY-HF Study
NCT05685303
This study is recruiting at 42 US sites in 23 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
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
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Alleviant Medical, Inc.
- Last updated on ClinicalTrials.gov
- August 14, 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
Arizona · 1
- Pima Heart and Vascular · Tucson, AZ
California · 5
- Memorial Care Long Beach Medical Center · Long Beach, CA
- UC Davis Medical Center · Sacramento, CA
- Scripps Clinical Research Services · San Diego, CA
- University of California San Francisco · San Francisco, CA
- Santa Barbara Cottage Hospital · Santa Barbara, CA
Florida · 5
- The Cardiac and Vascular Institute (TCAVI) · Gainesville, FL
- HCA Florida Memorial Hospital · Jacksonville, FL
- NCH Research Institute · Naples, FL
- Advent Health Orlando · Orlando, FL
- Ascension Sacred Heart · Pensacola, FL
Georgia · 1
- Atlanta VA Health Care System · Decatur, GA
Illinois · 1
- Midwest Cardiovascular Institute · Naperville, IL
Indiana · 1
- Indiana University · Indianapolis, IN
Kentucky · 1
- St. Elizabeth Healthcare · Edgewood, KY
Louisiana · 2
- Cardiovascular Institute of the South · Houma, LA
- University Medical Center New Orleans · New Orleans, LA
Maryland · 1
- Johns Hopkins Medical Institution · Baltimore, MD
Massachusetts · 2
- Boston Medical Center · Boston, MA
- Brigham and Women's Hospital · Boston, MA
Michigan · 1
- VA Ann Arbor · Ann Arbor, MI
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 York · 2
- New York University · New York, NY
- Stony Brook Medicine · Stony Brook, 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
Oklahoma · 1
- South Oklahoma Heart Research, LLC. · Oklahoma City, OK
Pennsylvania · 1
- Pinnacle Health Cardiovascular Institute · Harrisburg, PA
South Carolina · 1
- Medical University of South Carolina · Charleston, SC
South Dakota · 1
- Monument Health · Rapid City, SD
Tennessee · 2
- Stern Cardiovascular Foundation · Germantown, TN
- Tennova Healthcare - Turkey Creek Medical Center · Knoxville, TN
Texas · 5
- Hendrick Health · Abilene, TX
- Austin Heart · Austin, TX
- UT Southwestern · Dallas, TX
- Baylor Scott & White Research Institute · Plano, TX
- Waco Cardiology · Waco, TX
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.