NCT06812533
Alleviant ALLAY-HFrEF Study
Enrolling by Invitation
NAAges 18+InterventionalTreatmentAlleviant Medical, Inc.
~350 participants
Updated 2026-06-03 on ClinicalTrials.gov
What's tested:Alleviant ALV1 SystemSham-Control
At a glance
Recruiting sites
0 of 61 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Composite Primary Endpoint
Measured over 12-Month
Conditions
Where it's being run
61 sites across 27 statesSpain7
Texas6
California4
Florida3
Massachusetts3
North Carolina3
Belgium3
Poland3
Study leadership
- Gregg Stone · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai
- James Udelson · PRINCIPAL_INVESTIGATOR · Tufts Medical Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
LVEF ≤ 40%
NYHA class II, III or ambulatory IV HF
Receiving optimal, maximally tolerated, stable GDMT
Exclusion
Advanced heart failure
Life-expectancy \< 12 months
Evidence of right heart dysfunction
What this trial measures
- Composite Primary Endpoint12-Month
The primary endpoint is a composite of all-cause mortality or cardiac transplantation or permanent left ventricular assist device (LVAD) and heart failure events.