Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction

Alleviant Medical, Inc.

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

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed 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

Device
Alleviant ALV1 System
Creation of interatrial shunt
Other
Sham-Control
Cardiac imaging

Locations (68)

Keck Medical Center of USC
Los Angeles, California
University California Los Angeles Medical Center
Los Angeles, California
UC Davis Medical Center
Sacramento, California
Scripps Clinical Research Services
San Diego, California
University of California San Francisco
San Francisco, California
Delray Medical Center
Delray Beach, Florida

Summary

Eligibility

Interventions

Locations (68)