Trials / Enrolling By Invitation
Enrolling By InvitationNCT05685303
Alleviant ALLAY-HF Study
Safety and Efficacy of the Alleviant System for No-Implant Interatrial Shunt Creation in Patients With Chronic Heart Failure
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- Sponsor
- Alleviant Medical, Inc. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Alleviant ALV1 System | Creation of interatrial shunt |
| OTHER | Sham-Control | Cardiac imaging |
Timeline
- Start date
- 2023-01-10
- Primary completion
- 2026-04-01
- Completion
- 2032-07-31
- First posted
- 2023-01-17
- Last updated
- 2025-10-23
Locations
90 sites across 13 countries: United States, Australia, Austria, Belgium, Canada, Georgia, Germany, Greece, Israel, Italy, New Zealand, Poland, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05685303. Inclusion in this directory is not an endorsement.