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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04065997
Other study ID # Apogee International
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date September 6, 2019
Est. completion date July 26, 2021

Study information

Verified date July 2021
Source Medtronic Cardiac Rhythm and Heart Failure
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

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.


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


Recruitment information / eligibility

Status Terminated
Enrollment 147
Est. completion date July 26, 2021
Est. primary completion date July 26, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Medtronic Cardiac Rhythm and Heart Failure

Countries where clinical trial is conducted

Australia,  Austria,  Belgium,  Denmark,  Finland,  Germany,  Italy,  Kazakhstan,  Lebanon,  Netherlands,  Norway,  Poland,  Serbia,  Spain,  Switzerland,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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