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
Qualifiers
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
Treatments tested in this trial
- Alleviant ALV1 System
- Sham-Control
Treatment groups
700 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov