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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Alleviant ALV1 System
DeviceCreation of interatrial shunt
Sham-Control
Other interventionCardiac imaging
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: TreatmentExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite Primary Endpoint
The primary endpoint is a composite of all-cause mortality or cardiac transplantation or permanent left ventricular assist device (LVAD) and heart failure events.
Time frame
12-MonthSponsors and contacts
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Source ClinicalTrials.gov