Heart Failure Clinical Trial
Alleviant ALLAY-HF Study
Summary
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
Inclusion Criteria:
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)
Exercise PVR < 1.8 WU
Ongoing stable GDMT
Exclusion Criteria:
Advanced heart failure
Presence of a pacemaker
Evidence of right heart dysfunction
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There are 4 Locations for this study
Springfield Illinois, 62769, United States
Houma Louisiana, 70360, United States
Rapid City South Dakota, 57701, United States
Abilene Texas, 79601, United States
Tbilisi , , Georgia
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