No phaseRecruiting
Alleviant ALLAY-HFrEF Study
Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
- Sponsor
- Alleviant Medical, Inc. (Industry)
- Enrolment
- 350 planned
- Conditions
- Heart Failure
- Interventions
- Alleviant ALV1 System; Sham-Control
- Ages
- adults, older adults
- Registry
- NCT06812533
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Composite Primary Endpoint
History
Primary completion expected
Last registry update
Started
Registered