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|
| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P180050 / PAS001 |
| Date Original Protocol Accepted |
08/16/2019
|
| Date Current Protocol Accepted |
01/20/2023
|
| Study Name |
Extended Phase BeAT-HF PAS
|
| Device Name |
BAROSTIM NEO® System
|
| Clinical Trial Number(s) |
NCT02627196
|
| General Study Protocol Parameters |
| Study Design |
Randomized Clinical Trial
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Concurrent Control
|
| Analysis Type |
Analytical
|
| Study Population |
Transit.Adolescent B(as adults): 18 yrs < 22 yrs
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The study is continued follow up of the IDE cohort with additional enrollments post-approval to determine if the device can reduce cardiovascular mortality and heart failure hospitalizations.
|
| Study Population |
For patients who remain symptomatic despite treatment with guideline-directed medical therapy, are NYHA Class III or Class II (who had a recent history of Class III), have a left ventricular ejection fraction less than or equal to 35%, a NT-proBNP < 1600 pg/ml and excluding patients indicated for Cardiac Resynchronization Therapy (CRT) according to AHA/ACC/ESC guidelines
|
| Sample Size |
480 subjects
|
| Key Study Endpoints |
Rate of events (cardiovascular death and/or heart failure hostpitalization) is lower in treatment arm than control arm.
|
| Follow-up Visits and Length of Follow-up |
Follow-up continues to post-approval study completion.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
1091 enrolled/ 467 randomized and 218 implanted
|
| Actual Number of Sites Enrolled |
92 sites enrolled, 73 sites enrolled subjects
|
| Patient Follow-up Rate |
2 weeks, 1, 1.5, 2, 3, 6, 9, 12, 24 months
Note: 6MHW and NT-proBNP were collected until 12 months
|
| Final Safety Findings |
The safety results were evaluated at 6 months of follow-up with 264 randomized subjects. The results were reviewed in P180050.
125 subjects with the implant were included in the safety evaluation. There were 121 subjects who were MANCE-Free, which lead to a MANCE-Free Rate of 96.8%.
|
| Final Effect Findings |
At the 6 month follow-up, 3 outcomes (6MHW, QoL, and NT-proBNP) were evaluated between the device and medical management arm. All 3 outcomes showed an improvement.
There was no statistically significant difference in performance between the device arm and control arm for mortality and morbidity (heart failure hospitalizations) over the duration of the study. Therefore, the primary endpoint was not met.
The secondary analysis evaluated the symptomatic improvement: 6MHW and NT-proBNP at 12 months and MLWHF (QoL) and NYHA Class at 12 and 24 months. There was improvement seen for the 6MHW (12 month), QoL and NYHA Class (24 months). At 12 months, the medical management arm showed a larger improvement for the NT-proBNP.
The Win Ratio was evaluated. The heart transplant/LVAD and MLWHF at 12 months showed a beneficial trend.
|
| Study Strengths & Weaknesses |
The study showed that the device provided symptomatic improvement at 6 months. There was symptomatic improvement found at 12 months; however, the improvement was not found in the NT-proBNP. Additionally, 6MHW test and NT-proBNP were not collected at 24 month follow up so it is unclear what the results would be for these metrics at 24 month follow up. Additionally, the primary endpoint was not met.
The sponsor states that the NT-proBNP results need caution when interpreting because large number of subjects began ARNI during follow up, particularly in the control arm at 12 months.
|
| Recommendations for Labeling Changes |
Labeling changes were made to incorporate the PAS results in P180050/S009
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