Alleviant ALLAY-HFrEF Study

Enrolling by invitation · Not applicable · Has a placebo group

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT06812533

Run by

Alleviant Medical, Inc.

People needed

350

Starts

2025-03-10

Expected to finish

2028-12-01

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• LVEF ≤ 40%
• NYHA class II, III or ambulatory IV HF
• Receiving optimal, maximally tolerated, stable GDMT

You may not qualify if…

• Advanced heart failure
• Life-expectancy < 12 months
• Evidence of right heart dysfunction

Where it is running

• UC Davis Medical Center — Sacramento, California, United States
• Scripps Clinical Research Services — San Diego, California, United States
• University of California San Francisco — San Francisco, California, United States
• Delray Medical Center — Delray Beach, Florida, United States
• Ascension Sacred Heart — Pensacola, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Atlanta VA Health Care System — Decatur, Georgia, United States
• Midwest Cardiovascular Institute — Naperville, Illinois, United States
• Cardiovascular Institute of the South — Houma, Louisiana, United States
• University Medical Center New Orleans — New Orleans, Louisiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Washington University - St Louis — St Louis, Missouri, United States
• Stony Brook Medicine — New York, New York, United States
• Rochester General Hospital — Rochester, New York, United States
• Mission Hospital — Asheville, North Carolina, United States
• Duke University Hospital — Durham, North Carolina, United States
• NC Heart and Vascular Research — Raleigh, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• ProMedica Toledo Hospital — Toledo, Ohio, United States
• Pinnacle Health Cardiovascular Institute — Harrisburg, Pennsylvania, United States
• Roper St. Francis Healthcare — Charleston, South Carolina, United States
• Keck Medical Center of USC — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.