Trials / Enrolling By Invitation
Enrolling By InvitationNCT06812533
Alleviant ALLAY-HFrEF Study
Safety and Efficacy of the Alleviant No-Implant Interatrial Shunt in Patients With Heart Failure and Reduced Ejection Fraction
- Status
- Enrolling By Invitation
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 350 (estimated)
- Sponsor
- Alleviant Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Alleviant ALV1 System | Creation of interatrial shunt |
| OTHER | Sham-Control | Cardiac imaging |
Timeline
- Start date
- 2025-03-10
- Primary completion
- 2028-12-01
- Completion
- 2028-12-01
- First posted
- 2025-02-06
- Last updated
- 2025-12-16
Locations
43 sites across 6 countries: United States, Belgium, Canada, Georgia, Poland, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06812533. Inclusion in this directory is not an endorsement.