Trials / Completed
CompletedNCT05133089
ALLEVIATE-HFrEF Study
Evaluation of the Safety and Feasibility of a Percutaneously Created Interatrial Shunt to Alleviate Heart Failure Symptoms in Patients With Chronic Heart Failure and Reduced Left Ventricular Ejection Fraction
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Alleviant Medical, Inc. · Industry
- Sex
- All
- Age
- 40 Years
- Healthy volunteers
- Not accepted
Summary
Patients with heart failure and reduced left ventricular ejection fraction (HFrEF, EF ≤ 40%) with mild to moderate functional limitation will be evaluated for treatment via creation of a no-implant interatrial shunt using clinical, echocardiographic, and invasive hemodynamic data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ALV1 System | The ALV1 system is designed to create a controlled size interatrial shunt via a proprietary intra-cardiac catheter. There is no temporary or permanent implant used to create or maintain the interatrial shunt. The therapy is intended to be delivered in a single procedure administered under general anesthesia in a cardiac catheterization laboratory. |
Timeline
- Start date
- 2021-08-10
- Primary completion
- 2022-03-10
- Completion
- 2022-06-01
- First posted
- 2021-11-24
- Last updated
- 2023-07-18
Locations
1 site across 1 country: Georgia
Source: ClinicalTrials.gov record NCT05133089. Inclusion in this directory is not an endorsement.