Apogee International

Medtronic Cardiac Rhythm and Heart Failure147 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

147

Conditions

Chronic Heart Failure

Interventions

HeartWare Ventricular Assist DeviceDEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements; * Enrollment into Apogee International will be comprised of newly enrolled, commercial use patients with the HeartWare HVAD System; * Patient is consented prior to the HVAD implant procedure. Exclusion Criteria: * Patient who is, or is expected to be inaccessible for follow-up; * Participation is excluded by local law; * Patient is currently enrolled or plans to enroll in concurrent drug/device study that may confound the PSR results.

Locations (31)

Outcomes

Primary Outcomes

Major adverse events

Major adverse events are defined to be occurrence of major infection, major bleeding, device malfunction, stroke or death.

Time frame: Implant to 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

St. Vincents Hospital

Sydney, Australia

Medical University of Vienna

Vienna, Austria

UZ Leuven - Campus Gasthuisberg

Leuven, Belgium

Aarhus Universitetshospital

Aarhus, Denmark

Helsinki University Hospital

Helsinki, Finland

Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

Bad Oeynhausen, Germany

Schuechtermann Klinik

Bad Rothenfelde, Germany

Deutsches Herzzentrum Berlin

Berlin, Germany

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

...and 21 more locations