Last updated on February 2020

Apogee International


Brief description of study

Medtronic is sponsoring the Apogee International registry to further confirm safety and efficacy of the HVAD System when used as intended, in "real world" clinical practice and to enhance scientific understanding of the implant procedure, optimized blood pressure management, anticoagulation/ antiplatelet therapies, logfile analysis and acoustic spectrum analysis in patients receiving a Medtronic HeartWare HVAD for bridge to transplant and destination therapy indications.

Detailed Study Description

Apogee International is a prospective, non-interventional, post-market, multi-site registry, conducted within Medtronic's Product Surveillance Registry (PSR) Platform. Enrollment into Apogee International will be comprised of newly implanted, commercial use patients with the HeartWare Ventricular Assist Device System (HVAD System).

Sites selected to participate are expected to collect data in at least one of these four

modules
  1. Logfile Download;
  2. Anti-coagulation / Anti-platelet Management;
  3. Blood Pressure (BP) Management;
  4. Acoustic Spectrum Analysis.

Clinical Study Identifier: NCT04065997

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Helsinki University Hospital

Helsinki, Finland
8.62miles
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