At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
In Brief
An observational study evaluating HeartWare Ventricular Assist Device for Chronic Heart Failure. Completed, enrolled 136 participants across 33 sites.
Detailed 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.
Study Details
Timeline
Interventions
The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).