Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
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|ClinicalTrials.gov Identifier: NCT03697980|
Recruitment Status : Active, not recruiting
First Posted : October 5, 2018
Last Update Posted : June 14, 2021
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.
|Condition or disease||Intervention/treatment|
|Chronic Heart Failure||Device: HeartWare Ventricular Assist Device|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||124 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform|
|Actual Study Start Date :||January 17, 2019|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
Device: HeartWare Ventricular Assist Device
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).
Other Name: HVAD
- Rate of major adverse events [ Time Frame: Implant to 12 months ]Major adverse events are defined to be occurrence of infection, bleeding, device malfunction, stroke or death.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697980