|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P140003 S111/ PAS001 |
| Date Original Protocol Accepted |
12/03/2024
|
| Date Current Protocol Accepted |
12/03/2024
|
| Study Name |
Impella CPSA/5.5 Real-World Pediatric Use Surv
|
| Device Name |
Impella CP with SmartAssist, Impella 5.5 with SmartAssist
|
| General Study Protocol Parameters |
| Study Design |
Active Surveillance
|
| Data Source |
External Registry
|
| Comparison Group |
Historical Control
|
| Analysis Type |
Descriptive
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Continue monitoring the performance of the Impella CP with SmartAssist and Impella 5.5 with SmartAssist systems in pediatric patients through the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Registry.
|
| Study Population |
Consecutive pediatric patients treated with the two systems that are entered into the ACTION Registry.
|
| Sample Size |
A total of 60 patients, with a minimum of 20 patients treated with Impella 5.5 with SmartAssist.
|
| Key Study Endpoints |
Survival and adverse events.
|
| Follow-up Visits and Length of Follow-up |
Through device explant
|
| Interim or Final Data Summary |
| Interim Results |
Safety Results:
A total of four device malfunctions occurred. One device malfunction was reported for the Impella CP with SmartAssist device and attributed to flow alarms. Three device malfunctions were reported for Impella 5.5 with SmartAssist devices and attributed to purge system block, difficulty with initial delivery and malfunction of an internal sensor used for aortic and ventricular placement signal monitoring, respectively
Reported adverse events include bleeding/major bleeding (4 subjects), cardiac arrhythmias- SVT requiring defibrillation or cardioversion (4 subjects), major infection/infection (3 subjects), neurological dysfunction (2 subjects), hemolysis (2 subjects), respiratory failure requiring re-intubation (2 subjects), right heart failure (2 subjects), hypertension (1 subject), renal dysfunction requiring dialysis or hemofiltration (1 subject), vascular injury (1 subject), VT requiring medication (1 subject), fungemia (1 subject), and hematoma at Impella cut down site (1 subject).
Effectiveness Results:
A total of twenty-two (22) left/systemic ventricular Impella devices were placed in twenty (20) subjects across fourteen (14) sites in the ACTION registry with a mean subject age of 16.1 years and mean BSA was 1.8 m2. The mean duration of use for Impella CP with SmartAssist was 11.5 days, and Impella 5.5 with SmartAssist was 42.5 days. Out of the eighteen subjects with left/systemic ventricular Impella device implant information reported, three subjects received an Impella CP with SmartAssist device, and fifteen subjects received an Impella 5.5 with SmartAssist device. One subject had an Impella 5.5 SmartAssist device implanted as a single ventricular assist device (SVAD).
|
| Actual Number of Patients Enrolled |
20
|
| Actual Number of Sites Enrolled |
14
|
| Patient Follow-up Rate |
Seventeen subjects met the criteria for end of study status. Fourteen subjects had the left/systemic ventricular Impella removed for transplant or recovery, two subjects had explant for transplant, and one device was removed due to malfunction. At the end of the study three subjects had devices not functioning normally. All the subjects who had their left/systemic ventricular Impella devices removed were alive at the time of the report. Three subjects are still being supported by the left/systemic Impella at the time of report.
|
