Trials / Completed
CompletedNCT05820451
Impella Real-World Surveillance of Patients Using Sodium Bicarbonate
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 312 (actual)
- Sponsor
- Abiomed Inc. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution | US commercially approved Abiomed left sided hemodynamic support devices (Impella) will be included. |
| DEVICE | Impella RP with Sodium Bicarbonate used as purge solution | US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included. |
Timeline
- Start date
- 2022-12-15
- Primary completion
- 2024-02-22
- Completion
- 2024-02-22
- First posted
- 2023-04-19
- Last updated
- 2024-09-04
Locations
20 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05820451. Inclusion in this directory is not an endorsement.