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Alleviant ALLAY-HFrEF Study

RecruitingNAAges 18 Years - anyAllAlleviant Medical, Inc.
NCT06812533 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Alleviant ALV1 System
  • Sham-Control
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Where

70 sites
Keck Medical Center of USC
Los Angeles, United States
University California Los Angeles Medical Center
Los Angeles, United States
UC Davis Medical Center
Sacramento, United States
Scripps Clinical Research Services
San Diego, United States
University of California San Francisco
San Francisco, United States
Delray Medical Center
Delray Beach, United States
Ascension Sacred Heart
Pensacola, United States
Tampa General Hospital
Tampa, United States

…and 62 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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