Trials / No Longer Available
No Longer AvailableNCT05710042
ALIVE Expended Access - Clinical Study
Clinical Study of the BioVentrix Revivent TC™ System for Treatment of Left Ventricular Aneurysms ALIVE-EA (American Less Invasive Ventricular Enhancement-Expanded Access)
- Status
- No Longer Available
- Phase
- —
- Study type
- Expanded Access
- Enrollment
- —
- Sponsor
- BioVentrix · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- —
Summary
A prospective, multi-center, single-arm study. This study will enroll a maximum of 35 subjects treated with the Revivent TC System.
Detailed description
The purpose of this study is to allow the continued use of the BioVentrix Revivent TC System for the treatment of LV antero-septal aneurysms/scars in patients with symptomatic heart failure while the pivotal trial for the BioVentrix Revivent TC System is continuing through the follow up phase and the PMA documentation is prepared and reviewed by FDA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Revivent TC System | The Revivent TC System is indicated for patients suffering from symptomatic heart failure referred for treatment of left ventricular antero-septal aneurysms/scars that are contiguous and includes both anterior and septal components. |
Timeline
- First posted
- 2023-02-02
- Last updated
- 2025-04-10
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT05710042. Inclusion in this directory is not an endorsement.