Heart Failure Clinical Trial
Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform
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 HeartWareâ„¢ Ventricular Assist Device (HVADâ„¢) for destination therapy.
The Apogee study is conducted within Medtronic's Product Surveillance Platform.
Full 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) (NCT03681210) 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.
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.
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There are 31 Locations for this study
Little Rock Arkansas, 72205, United States
San Diego California, 92103, United States
San Francisco California, 94143, United States
Stanford California, 94305, United States
Aurora Colorado, 80045, United States
Orlando Florida, 32804, United States
Chicago Illinois, 60611, United States
Oak Lawn Illinois, 60453, United States
Kansas City Kansas, 66160, United States
Louisville Kentucky, 40202, United States
Baltimore Maryland, 21201, United States
Baltimore Maryland, 21287, United States
Boston Massachusetts, 02111, United States
Boston Massachusetts, 02114, United States
Detroit Michigan, 48202, United States
Rochester Minnesota, 55905, United States
Saint Louis Missouri, 63110, United States
New York New York, 10016, United States
New York New York, 10032, United States
Cincinnati Ohio, 45219, United States
Columbus Ohio, 43210, United States
Tulsa Oklahoma, 74104, United States
Portland Oregon, 97225, United States
Pittsburgh Pennsylvania, 15213, United States
Nashville Tennessee, 37232, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Houston Texas, 77030, United States
Salt Lake City Utah, 84132, United States
Norfolk Virginia, 23507, United States
Richmond Virginia, 23298, United States
Seattle Washington, 98195, United States
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