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Alleviant ALLAY-HFrEF Study

Alleviant ALLAY-HFrEF Study

Recruiting
18 years and older
All
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

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

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

Study details
    Heart Failure

NCT06812533

Alleviant Medical, Inc.

15 August 2026

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