N/A
Completed N=540
HeartMate 3 ELEVATE™ Registry
Source: ClinicalTrials.gov NCT02497950 ↗Enrolled (actual)
540
Serious AEs
84.4%
Results posted
Mar 2025
Primary outcomePrimary: Survival — 293 Participants
Summary
Evaluate real-world experience of HeartMate 3 (HM3) in post-approval setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival |
293 | — |
| SECONDARY EuroQoL-5D-5L (EQ-5D-5L) VAS |
35; 67; 67; 66; 65; 64 | — |
| SECONDARY Six Minute Walk Test (6MWT) |
102.9; 370.7; 343.8; 356.7; 328.9; 301.2 | — |
| SECONDARY New York Heart Association (NYHA) Classification |
29; 71; 54; 3 | — |
| SECONDARY Adverse Events |
10; 79; 2; 12; 12; 155 | — |
| SECONDARY Device Malfunctions |
1; 1; 2; 1; 16; 1 | — |
| SECONDARY Reoperations |
774 | — |
| SECONDARY Rehospitalizations |
1418 | — |
Eligibility Criteria
Inclusion:
- Patient consented to registry data collection
- Patient has met the HeartMate 3 commercially approved labeling indication and is implanted with the HM3.
Data sourced from ClinicalTrials.gov (NCT02497950). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.