Clinical trial NCT04065997: Apogee International
Official title: Apogee International
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Chronic Heart Failure
Lead sponsor: Medtronic Cardiac Rhythm and Heart Failure
Sponsor class: INDUSTRY
First posted: 2019-08-22
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Major adverse events
timeFrame: Implant to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: St. Vincents Hospital
city: Vienna
country: Austria
facility: Medical University of Vienna
city: Leuven
country: Belgium
facility: UZ Leuven - Campus Gasthuisberg
city: Aarhus
country: Denmark
facility: Aarhus Universitetshospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital
city: Bad Oeynhausen
country: Germany
facility: Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
city: Bad Rothenfelde
country: Germany
facility: Schuechtermann Klinik
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin
city: Duesseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Leipzig
country: Germany
facility: Herzzentrum Leipzig GmbH
city: Magdeburg
country: Germany
facility: Otto von Guericke Universitat - Universitätsklinikum Magdeburg
city: Tübingen
country: Germany
facility: Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
city: Bologna
country: Italy
facility: Azienda Ospedaliero Universitaria S. Orsola Malpighi Bologna
city: Milano
country: Italy
facility: Ospedale San Raffaele
city: Palermo
country: Italy
facility: ISMETT
city: Astana
country: Kazakhstan
facility: National Research Cardiac Surgery Center
city: Beirut
country: Lebanon
facility: Al Rassoul Al Azam Hospital - Beirut Cardiac Institute
city: Leiden
country: Netherlands
facility: Leiden Universitair Medisch Centrum (LUMC)
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Oslo
country: Norway
facility: Oslo Universitetssykehus-Rikshospitalet
city: Warsaw
country: Poland
facility: Instytut Kardiologii
city: Belgrade
country: Serbia
facility: Klinicki Centar Srbije
city: A Coruña
country: Spain
facility: Hospital Universitario da Coruña
city: Barcelona
country: Spain
facility: Hospital Universitari de Bellvitge
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
city: Ankara
country: Turkey
facility: Ankara City Hospital
city: İzmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi
city: Harefield
country: United Kingdom
facility: Royal Brompton & Harefield NHS Foundation Trust - Harefield Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
Study officials:
References: