|
|
| General |
| Study Status |
Progress Inadequate |
Application Number /
Requirement Number |
P100047 S090/ PAS002 |
| Date Original Protocol Accepted |
07/26/2018
|
| Date Current Protocol Accepted |
02/12/2021
|
| Study Name |
ENDURANCE PAS
|
| Device Name |
HeartWare™ HVAD™ System
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The objective of the study is to estimate patient survival free of death, disabling stroke, or device malfunction or failure requiring exchange, explantation or urgent transplantation following HeartWare Ventricular Assist Device (HVAD) implantation for destination therapy (DT).
This post-approval study (PAS) is a prospective, observational, multi-site study conducted through Medtronic’s Product Surveillance Registry (PSR).
|
| Study Population |
Patients using the HVAD system as destination therapy.
|
| Sample Size |
The PAS cohort will be comprised of 300 newly enrolled patients. This sample size will estimate the primary endpoint rate at 24 months post-original implant within 6.0%. The following assumptions were used:
- Two-sided 95% confidence intervals will be computed
- Goal is to estimate the primary objective survival rate at 2 years
- Survival rate at 24 months is 59.2%, which is based on the Endurance Supplemental HeartWare success rate using data through March 27, 2017 (data pull May 30, 2017).
- Attrition will be 10% from implant to 24 months, primarily consisting of transplants
Approximately 50 sites will participate in the PAS.
|
| Key Study Endpoints |
The primary endpoint/objective is survival free of disabling stroke or device malfunction requiring exchange, explant, or urgent transplant.
Secondary endpoints:
- Observed early stroke rate (stroke occurring =2 years post-implant), and stroke risk factors.
- Late stroke rate (stroke occurring >2 years post-implant) and to evaluate risk factors for late stroke.
- Stroke severity for all subjects who experience a stroke on device while in this study. Stroke severity will be assessed through modified Rankin Scale (mRS) scoring.
Additional endpoints:
Effectiveness of Invasive Blood Pressure Monitoring (IBPM), a summary of neurologic dysfunction events (ischemic cerebrovascular accidents, hemorrhagic cerebrovascular accidents, and transient ischemic attacks), overall survival on device, INTERMACS adverse event rates, quality of life measures (measured by EuroQol EQ-5D-DL and Kansas City Cardiomyopathy Questionnaire), and functional status (measured by the 6-minute walk test).
|
| Follow-up Visits and Length of Follow-up |
Subjects will be followed through five years post-implant
|
| Interim or Final Data Summary |
| Interim Results |
Freedom from stroke through six-months is approximately 83%, and through 12-months is approximately 72%. Overall survival on HVAD through six-months is approximately 80%, and through 12-months is approximately 69%.
|
| Actual Number of Patients Enrolled |
277
|
| Actual Number of Sites Enrolled |
43
|
| Patient Follow-up Rate |
273 patients have been evaluated at discharge, 230 patients have been evaluated at the 3-month follow-up visit, 201 patients have been evaluated at the 6-month follow-up visit, 149 patients have been evaluated at the 12-month visit, and 10 patients have been evaluated at the 18-month visit.
|
| Study Strengths & Weaknesses |
Follow-up rate is fairly high for all visits except the 18-month and 24-month visits. However, the completion rate for several important measures, including the modified Rankin Scale scores an assessment of stroke severity, are very low. This means interpretation of the available results may not reflect the experience of all study participants.
|
