Trials / Active Not Recruiting
Active Not RecruitingNCT04465201
The Smart Pump Study
Advanced Impella® SmartAssist® System for Patient Monitoring & Treatment: The Smart Pump Study
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Abiomed Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
To demonstrate that the Impella® Hemodynamic Platform (the "Study Device") is safe, and measurements obtained are as good as currently used methods. These measurements include how much pressure the heart is generating and how much blood your heart is pumping during the PCI.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Impella CP with Smart Assist (Circulatory Support System) | Subjects will receive the Impella® with the Impella® Hemodynamics Platform prior to High risk percutaneous coronary intervention (HRPCI). Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be consented for follow-up through discharge from the index HRPCI admission. |
Timeline
- Start date
- 2020-11-02
- Primary completion
- 2022-12-31
- Completion
- 2022-12-31
- First posted
- 2020-07-10
- Last updated
- 2022-10-24
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04465201. Inclusion in this directory is not an endorsement.