|
|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P160054 S031/ PAS001 |
| Date Original Protocol Accepted |
12/17/2020
|
| Date Current Protocol Accepted |
|
| Study Name |
Heartmate 3 Real-World Pediatric Use Surveillance
|
| Device Name |
HeartMate 3 Left Ventricular Assist System (HM3 LVAS)
|
| 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 B (as adults) : 18-21 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Registry-based surveillance. The objective of the surveillance is to continue to monitor the performance of the HeartMate 3 LVAS in pediatric patients.
|
| Study Population |
Pediatric patients with advanced refractory left ventricular heart failure and with an appropriate body surface area who require short- or long-term mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy).
|
| Sample Size |
All consecutive pediatric patients treated with the HeartMate 3 LVAS within the first 2 years after the PMA approval that are entered into the Advanced Cardiac Therapies Improving Outcomes Network (ACTION) Registry.
|
| Key Study Endpoints |
Patient outcomes (e.g., transplanted, expired, and explanted for recovery) and adverse events at 3, 6, 12, and 24 months.
|
| Follow-up Visits and Length of Follow-up |
2 years
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
95
|
| Actual Number of Sites Enrolled |
59 centers in the ACTION Registry
|
| Patient Follow-up Rate |
3-month follow-up: 46 subjects received heart transplant (48.4%); 4 expired (4.2%); 3 subjects terminated participation due to other causes
(3.2%); and a total of 42 subjects remained on HM3 support (44.2%)
6-month follow-up: an additional 20 subjects received a transplant (for a total of 66 subjects who received a heart transplant at 6 months
(69.5%)); 1 additional subject expired (for a total of 5 subjects who expired at 6 months (5.3%)); 1 additional subject transferred to nonpa
|
| Final Safety Findings |
3-months*: Bleeding 11 subjects (11.6%); major infection 24 subjects (25.3%); respiratory failure 4 subjects (4.2%); right heart failure 12
subjects (12.6%), stroke 4 subjects (4.2%)
6-months*: Bleeding 11 subjects (11.6%); major infection 29 subjects (30.5%); respiratory failure 4 subjects (4.2%); right heart failure 12
subjects (12.6%), stroke 4 subjects (4.2%)
12-months*: Bleeding 11 subjects (11.6%); major infection 30 subjects (31.6%); respiratory failure 4 subjects (4.2%); right heart failure 12
subjects (12.6%), stroke 5 subjects (5.3%)
*Please note events are cumulative at each time point
|
| Final Effect Findings |
Survival rates at 3, 6, and 12 months were 94.6%, 91.6%, and 85.5%
|
