N/A
Completed N=124
Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
Source: ClinicalTrials.gov NCT03697980 ↗Enrolled (actual)
124
Serious AEs
87.9%
Results posted
Dec 2023
Primary outcomePrimary: Rate of Major Adverse Events — 18.2 % probability of freedom from major AE
Summary
Medtronic is sponsoring the Apogee study to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation/ antiplatelet therapy in patients receiving a Medtronic HeartWare™ Ventricular Assist Device (HVAD™) for destination therapy.
The Apogee study is conducted within Medtronic's Product Surveillance Platform.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Major Adverse Events |
18.2 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects consented to participate in DT PAS are eligible for participation in Apogee.
Exclusion Criteria
- There are no exclusion criteria unique to Apogee.
Data sourced from ClinicalTrials.gov (NCT03697980). 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.