Apogee International

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Device: HeartWare Ventricular Assist Device

Detailed 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 Type: Observational
• Enrollment (Actual): 147

Contacts and Locations

Study Locations

• Australia
  • Sydney, Australia
    • St. Vincents Hospital
• Austria
  • Vienna, Austria
    • Medical University of Vienna
• Belgium
  • Leuven, Belgium
    • UZ Leuven - Campus Gasthuisberg
• Denmark
  • Aarhus, Denmark
    • Aarhus Universitetshospital
• Finland
  • Helsinki, Finland
    • Helsinki University Hospital
• Germany
  • Bad Oeynhausen, Germany
    • Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
  • Bad Rothenfelde, Germany
    • Schuechtermann Klinik
  • Berlin, Germany
    • Deutsches Herzzentrum Berlin
  • Duesseldorf, Germany
    • Universitätsklinikum Düsseldorf
  • Hamburg, Germany
    • Universitätsklinikum Hamburg-Eppendorf
  • Hannover, Germany
    • Medizinische Hochschule Hannover
  • Leipzig, Germany
    • Herzzentrum Leipzig GmbH
  • Magdeburg, Germany
    • Otto von Guericke Universitat - Universitätsklinikum Magdeburg
  • Tübingen, Germany
    • Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
• Italy
  • Bologna, Italy
    • Azienda Ospedaliero Universitaria S. Orsola Malpighi Bologna
  • Milano, Italy
    • Ospedale San Raffaele
  • Palermo, Italy
    • Ismett
• Kazakhstan
  • Astana, Kazakhstan
    • National Research Cardiac Surgery Center
• Lebanon
  • Beirut, Lebanon
    • Al Rassoul Al Azam Hospital - Beirut Cardiac Institute
• Netherlands
  • Leiden, Netherlands
    • Leiden Universitair Medisch Centrum (LUMC)
  • Utrecht, Netherlands
    • University Medical Center Utrecht
• Norway
  • Oslo, Norway
    • Oslo Universitetssykehus-Rikshospitalet
• Poland
  • Warsaw, Poland
    • Instytut Kardiologii
• Serbia
  • Belgrade, Serbia
    • Klinicki Centar Srbije
• Spain
  • A Coruña, Spain
    • Hospital Universitario da Coruña
  • Barcelona, Spain
    • Hospital Universitari de Bellvitge
• Switzerland
  • Zürich, Switzerland
    • Universitatsspital Zurich
• Turkey
  • Ankara, Turkey
    • Ankara City Hospital
  • İzmir, Turkey
    • Ege Universitesi Tip Fakultesi Hastanesi
• United Kingdom
  • Harefield, United Kingdom
    • Royal Brompton & Harefield NHS Foundation Trust - Harefield Hospital
  • Newcastle, United Kingdom
    • Freeman Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients intended to be implanted with a HeartWare HVAD per the current (local) guidelines, are eligible for enrollment into Apogee International and must be consented for Apogee International prior to the HVAD implant.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Patients implanted with HVAD System; Patients intended to be implanted with a HeartWare HVAD per the current (local) guidelines, are eligible for enrollment into Apogee International and must be consented for Apogee International prior to the HVAD implant.

Device: HeartWare Ventricular Assist Device; 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).; Other Names: HVAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major adverse events	Major adverse events are defined to be occurrence of major infection, major bleeding, device malfunction, stroke or death.	Implant to 12 months

Collaborators and Investigators

• Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2019
• Primary Completion (Actual): July 26, 2021
• Study Completion (Actual): July 26, 2021

Study Registration Dates

• First Submitted: August 21, 2019
• First Submitted That Met QC Criteria: August 21, 2019
• First Posted (Actual): August 22, 2019

Study Record Updates

• Last Update Posted (Actual): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 27, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: Apogee International

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes