Alleviant ALV1 Shunt for HFrEF: a Safe Test in Eligible Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, sham-controlled trial compares the Alleviant ALV1 interatrial shunt to a sham procedure in adults with HFrEF. The study is double-blind for patients and observers and aims to determine safety and efficacy. Eligible participants have LVEF ≤40% and NYHA class II–IV symptoms despite optimized guideline-directed medical therapy. Key exclusions include advanced HF, life expectancy under 12 months, and right heart dysfunction. The trial is sponsored by Alleviant Medical, with sites at USC Keck, UCLA, and UC Davis.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

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

Where it's running

• Keck Medical Center of USC
  Los Angeles, California, United States Recruiting
• University California Los Angeles Medical Center
  Los Angeles, California, United States Recruiting
• UC Davis Medical Center
  Sacramento, California, United States Recruiting
• Scripps Clinical Research Services
  San Diego, California, United States Recruiting
• University of California San Francisco
  San Francisco, California, United States Recruiting
• Delray Medical Center
  Delray Beach, Florida, United States Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Gregg Stone — Icahn School of Medicine at Mount Sinai
• Study coordinator: Stacia Kraus
• Email: stacia.kraus@alleviantmedical.com
• Phone: 612-387-4552

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.