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|
| 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
|
| Study Population |
Child: 2-12 yrs,
Adolescent: 13-18 yrs,
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| 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 |
Study Results
Adverse events include major infection (2 subjects), major bleeding (1 subject), neurological dysfunction (1 subject), hemolysis (1 subject), cardiac arrhythmias - SVT requiring defibrillation or cardioversion (1 subject), VT requiring drug treatment (1 subject), right heart failure (1 subject), respiratory failure requiring re-intubation (1 subject) and hypertension (1 subject).
Effectiveness Results
A total of eight left/systemic ventricular Impella devices were placed in eight subjects across six sites with a mean age of 17.7 years, and mean BSA of 1.9 m2. The mean duration of use was 42 days. Three subjects received an Impella CPSA device, and five subjects received an Impella 5.5 SA device.
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| Actual Number of Patients Enrolled |
8
|
| Actual Number of Sites Enrolled |
6
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| Patient Follow-up Rate |
At the time of the report, five subjects had their device removed and reached end-of-study status, while two subjects continued to receive left/systemic ventricular Impella support, and one subject had device removed but is missing the end of study status. Among the five subjects who had the left/systemic ventricular Impella devices removed, four subjects had their device removed due to transplant or recovery, and one subject had their Impella CPSA removed due to unsuccessful attempts to troubleshoot several flow alarms resulting in device malfunction on day 22 of the device support. The subject remained stable and there were no associated adverse events resulting from the device malfunction. All the subjects who had their left/systemic ventricular Impella devices removed were alive at the time of the report.
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