Trials / Withdrawn
WithdrawnNCT05695716
CSI Percutaneous Ventricular Assist Device (pVAD) Second in Human Study
Cardiovascular Systems, Inc. (CSI) Percutaneous Ventricular Assist Device (pVAD) Second in Human Study
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to collect data on safety and device performance on the CSI pVAD System used to support hemodynamic stability during HR-PCIs 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
- 2023-04-05
- Primary completion
- 2023-07-17
- Completion
- 2023-07-17
- First posted
- 2023-01-25
- Last updated
- 2024-01-17
Locations
1 site across 1 country: Georgia
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05695716. Inclusion in this directory is not an endorsement.