Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
147 participants
OBSERVATIONAL
2019-09-06
2021-07-26
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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).
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Medtronic Cardiac Rhythm and Heart Failure
INDUSTRY
Responsible Party
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Locations
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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
Medizinische Hochschule Hannover
Hanover, , Germany
Herzzentrum Leipzig GmbH
Leipzig, , Germany
Otto von Guericke Universitat - Universitätsklinikum Magdeburg
Magdeburg, , Germany
Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
Tübingen, , Germany
Azienda Ospedaliero Universitaria S. Orsola Malpighi Bologna
Bologna, , Italy
Ospedale San Raffaele
Milan, , Italy
ISMETT
Palermo, , Italy
National Research Cardiac Surgery Center
Astana, , Kazakhstan
Al Rassoul Al Azam Hospital - Beirut Cardiac Institute
Beirut, , Lebanon
Leiden Universitair Medisch Centrum (LUMC)
Leiden, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Oslo Universitetssykehus-Rikshospitalet
Oslo, , Norway
Instytut Kardiologii
Warsaw, , Poland
Klinicki Centar Srbije
Belgrade, , Serbia
Hospital Universitario da Coruña
A Coruña, , Spain
Hospital Universitari de Bellvitge
Barcelona, , Spain
UniversitätsSpital Zürich
Zurich, , Switzerland
Ankara City Hospital
Ankara, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, , Turkey (Türkiye)
Royal Brompton & Harefield NHS Foundation Trust - Harefield Hospital
Harefield, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Countries
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Other Identifiers
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Apogee International
Identifier Type: -
Identifier Source: org_study_id
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