Alleviant ALLAY-HF Study
ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorAlleviant Medical, Inc.
About this trial
Prospective, multicenter, randomized, sham-controlled, double blinded, adaptive study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the Alleviant ALV1 System in patients with HFpEF/HFmrEF.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Symptomatic HFpEF/HFmrEF with LVEF greater than or equal to 40%
NYHA Class II, III or ambulatory IV
Exercise right heart catheterization*
Elevated left atrial pressure during exercise right heart catheterization (greater than or equal to 25 mmHg)
Disqualifiers
Advanced heart failure
Presence of a pacemaker
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
700 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 mortality, heart failure events and quality of life based on Kansas City Cardiomyopathy Questionnaire (KCCQ) calculated at 12 months. KCCQ responses are provided along a rating scale from 0-100 with a higher score indicating better health.
Time frame
12-monthSponsors and contacts
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Source ClinicalTrials.gov