Alleviant ALLAY-HFrEF Study

What this study is about

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.

Who can join (things the study team will check)

✅ You may be able to join if…

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

🚫 You may not be able to join if…

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

Where this trial is running

• Keck Medical Center of USC, Los Angeles, California, United States
• University California Los Angeles Medical Center, Los Angeles, California, United States
• 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

+ 55 more sites.

Who to contact

Stacia Kraus · 612-387-4552 · stacia.kraus@alleviantmedical.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT06812533.