|
|
| General |
| Study Status |
Progress Adequate |
| Application Number |
P100047 / PAS001 |
| Date Current Protocol Accepted |
01/15/2016
|
| Study Name |
Newly Enrolled (HW-PAS-01)
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
External Registry
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Design Description |
Objective: To evaluate the safety and efficacy of the HeartWare System in a commercial setting using data from patients enrolled in the INTERMACS database. The HeartWare VAS performance in a ¿real world¿ setting will be compared to other continuous flow, intra-corporeal left ventricular assist devices in the INTERMACS database, as assessed by primary endpoint of success and secondary endpoints including INTERMACS adverse event rates.
Design: This is a multi-center, prospective, contemporaneously controlled trial of newly enrolled patients. There will be two groups - the Treatment group, patients who receive a HeartWare VAS, and a contemporaneous Control group, patients who receive a continuous flow, intra-corporeal LVAD other than the HeartWare VAS.
|
| Study Population Description |
Patients entered into the INTERMACS database who receive a HeartWare System (treatment group) and contemporaneous patients who receive a continuous flow, intra-corporeal LVAD other than HeartWare (control).
Inclusion criteria:
¿ FDA approved durable mechanical circulatory support device implanted
after PMA approval of the HeartWare System
¿ Signed consent for registry
Exclusion criteria:
¿ Prisoner
¿ Consent form not signed
|
| Sample Size |
600 HeartWare patients and 600 control patients of continuous flow, intra- corporeal LVADs other than the HeartWare System. A total of 1200 patients are required to satisfy the subgroups of interest (i.e. gender and race).
For Scenarios 1-2:
At least 310 implanted females and at least 310 implanted non-whites (155
HeartWare and 155 Control), calculated using a non-inferiority with a 10%
margin, using a one-sided 5% significance level, will provide 90% power at
180 days. At least 12 non-IDE sites will be included. For Scenarios 3:
The sample size of 155 patients will provide greater than 90% power to test the study hypothesis that the lower 95% (5% significance level) one-sided confidence limit is greater than 80%.
|
| Data Collection |
The primary endpoint is success (alive, transplanted, or explanted for recovery) at 180 days on the originally implanted device. Patients who are explanted for recovery must survive at least 60 days post-explant. The
denominator of the simple proportion includes all enrolled and implanted patients. This will be stratified by gender and race.
Secondary endpoints are:
¿ Overall survival on device
¿ Re-hospitalizations
¿ INTERMACS adverse events
¿ Quality of Life measures (as measured by the EuroQol EQ-5D-5L and
KCCQ)
¿ Functional Status (as measured by the 6 minute walk and / or VO2 max)
¿ Post-stroke QOL, Functional and Neurocognitive assessments
Device Malfunction and thrombus are also captured.
The INTERMACS database does not capture Modified Rankin Scale (MRS) scores, but it does capture data from which an MRS score may be derived. An independent neurologist will analyze on a blinded basis INTERMACS data for patients who have experienced a stroke event to impute MRS scores.
|
| Follow-up Visits and Length of Follow-up |
Two years post implant
Follow-up will occur at discharge, 1 week, 1 month, 3 months, 6 months
|
