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Clinical Trial Summary

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.


Clinical Trial 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 five modules: 1. Logfile Download; 2. Anti-coagulation / Anti-platelet Management; 3. Blood Pressure (BP) Management; 4. Acoustic Spectrum Analysis; 5. Infection Control ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04065997
Study type Observational [Patient Registry]
Source Medtronic Cardiac Rhythm and Heart Failure
Contact
Status Terminated
Phase
Start date September 6, 2019
Completion date July 26, 2021

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