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Clinical Trial 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.


Clinical Trial Description

The Apogee study is a prospective, observational, post-market, on-label, multi-site study in Destination Therapy patients. Patients participating in the Medtronic Destination Therapy (DT) Post Approval Study (PAS) are eligible for participation in Apogee. Patients enrolled in Apogee will be followed under the Apogee study for one-year post-implant. After participation in Apogee ends, patients will remain enrolled in DT PAS and will continue to be followed as outlined in the DT PAS protocol. The total estimated study duration is 33 months. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03697980
Study type Observational [Patient Registry]
Source Medtronic Cardiac Rhythm and Heart Failure
Contact Apogee Manager
Phone 508-532-4722
Email samantha.ly@medtronic.com
Status Not yet recruiting
Phase
Start date October 22, 2018
Completion date October 2020

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