Trials / Completed
CompletedNCT05315544
Cardiovascular Systems Inc. (CSI) pVAD First in Human Study
CSI Percutaneous Ventricular Assist Device (pVAD) First in Human Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This study will collect initial clinical data on the CSI pVAD system to inform device design and finalization.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | CSI pVAD system | The CSI percutaneous ventricular assist device (pVAD) is being investigated as a temporary left ventricular system intended to support and/or provide hemodynamic stability during high-risk percutaneous coronary interventions. |
Timeline
- Start date
- 2022-03-14
- Primary completion
- 2022-03-16
- Completion
- 2022-03-16
- First posted
- 2022-04-07
- Last updated
- 2023-12-11
Locations
1 site across 1 country: Georgia
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05315544. Inclusion in this directory is not an endorsement.