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Alleviant ALLAY-HFrEF Study

RECRUITINGN/ASponsored by Alleviant Medical, Inc.
Actively Recruiting
PhaseN/A
SponsorAlleviant Medical, Inc.
Started2025-03-10
Est. completion2028-12
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations40 sites
View on ClinicalTrials.gov →

NCT06812533

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions2

Heart DiseaseHeart Failure

Locations40 sites

Keck Medical Center of USC
Los Angeles, California, 90033
Michael Fong, MD
University California Los Angeles Medical Center
Los Angeles, California, 90095
Richard Cheng, MD
UC Davis Medical Center
Sacramento, California, 95817
Tai Pham, MD
Scripps Clinical Research Services
San Diego, California, 92121
Rajeev Mohan, MD
University of California San Francisco
San Francisco, California, 94143
Liviu Klein, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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