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Recruiting NCT06812533

Alleviant ALLAY-HFrEF Study

Conditions: Heart Failure

Sex: All

Ages: 18 Years – N/A

Healthy volunteers: No

Phase: NA

Enrollment: 350

Sponsor: Alleviant Medical, Inc.

Location: Keck Medical Center of USC Los Angeles California

Summary

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

Inclusion Criteria: * LVEF ≤ 40% * NYHA class II, III or ambulatory IV HF * Receiving optimal, maximally tolerated, stable GDMT Exclusion Criteria: * Advanced heart failure * Life-expectancy \< 12 months * Evidence of right heart dysfunction

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06812533). StuddyBuddy aggregates publicly available trial information.