Alleviant ALLAY-HFrEF Study
Sponsored by Alleviant Medical, Inc.
About this study
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.
Where this study is enrolling (2)
- Call 404-321-6111
Atlanta VA Health Care System
Decatur, Georgia
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Midwest Cardiovascular Institute
Naperville, Illinois
Who can participate
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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Trial data sourced from ClinicalTrials.gov.