Alleviant ALLAY-HFrEF Study
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlleviant Medical, Inc.
About this trial
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 criteria
Qualifiers
LVEF ≤ 40%
NYHA class II, III or ambulatory IV HF
Receiving optimal, maximally tolerated, stable GDMT
Disqualifiers
Advanced heart failure
Life-expectancy < 12 months
Evidence of right heart dysfunction
Trial design
Treatments tested in this trial
- Alleviant ALV1 System
- Sham-Control
Treatment groups
350 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov