|
|
| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P140003 S088/ PAS001 |
| Date Original Protocol Accepted |
08/18/2022
|
| Date Current Protocol Accepted |
04/27/2023
|
| Study Name |
Impella RW Surveillance of Pts using Sodium Bicarb
|
| Device Name |
Impella 2.5 System, Impella CP System, Impella CP with SmartAssist System, Impella 5.0 System, Impella LD System,Impella 5.5 with SmartAssist System
|
| General Study Protocol Parameters |
| Study Design |
Comprehensive/Linked/RegistryBased Surveillance
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Concurrent & Historical Control
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
A multicenter, observational, records review study of routine clinical care. Subjects are from post-market cohorts and new
enrollment.
|
| Study Population |
Device: The study will include up to 60 sites from the US. The population enrolled in this study are all subjects who received an
Impella in which a bicarbonate-based purge solution was used. Comparator: The study will include up to 60 sites from the US. The
population enrolled in this study are all subjects who received an Impella in which a heparin-based purge solution was used.
|
| Sample Size |
A sample size of 300 subjects is proposed for the study based on the following assumptions:
Event rate 6%
Target margin of error of +/- 3% (the width of 95% confidence interval of 6%)
While the sample size with the above assumptions is 275, the additional subjects ensure the target 3% margin of error for a
potentially higher event rate in the all-comers population enrolled in the study.
For Impella RP, the sample size will be the number of subjects available at the time the left-sided device population completes
enrollment, up to 30 subjects. As the use of Impella RP is an order of magnitude less than the left-sided devices, a target margin of
error is not feasible for this population.
|
| Key Study Endpoints |
1. Left-sided devices (Impella 2.5, Impella CP, Impella LD, Impella 5.0 and Impella 5.5): Hierarchical composite of
stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus [Time Point: Discharge]
2. Impella RP: Hierarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT) [Time Point: Discharge]
1. Bleeding, BARC greater than or equal to 3 [Time Point: Discharge]
2. For left-sided devices: Thrombotic events excluding LV thrombus, stroke and TIA [Time Point: Discharge]
3. For Impella RP: Thrombotic events excluding pulmonary thromboemboli and DVT [Time Point: Discharge]
|
| Follow-up Visits and Length of Follow-up |
1. Left-sided devices (Impella 2.5, Impella CP, Impella LD, Impella 5.0 and Impella 5.5): Hierarchical composite of
stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus [Time Point: Discharge]
2. Impella RP: Hierarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT) [Time Point: Discharge]
1. Bleeding, BARC =3 [Time Point: Discharge]
2. For left-sided devices: Thrombotic events excluding LV thrombus, stroke and TIA [Time Point: Discharge]
3. For Impella RP: Thrombotic events excluding pulmonary thromboemboli and DVT [Time Point: Discharge]
|
