Apogee International

Terminated

• Conditions: Chronic Heart Failure
• Interventions: Device: HeartWare Ventricular Assist Device

• Registration Number: NCT04065997
• Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

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

Study Timeline

• Study First Submitted: 2019-08-21
• Study First Submitted QC: 2019-08-21
• Study First Posted: 2019-08-22
• Study Start: 2019-09-06
• Status Verified: 2021-07
• Primary Completion: 2021-07-26
• Study Completion: 2021-07-26
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 147

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients implanted with HVAD System	HeartWare Ventricular Assist Device	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.

Primary Outcome Measures

Name	Time	Method
Major adverse events	Implant to 12 months	Major adverse events are defined to be occurrence of major infection, major bleeding, device malfunction, stroke or death.

Trial Locations

Locations (31)

St. Vincents Hospital; 🇦🇺 Sydney, Australia

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Medical University of Vienna; 🇦🇹 Vienna, Austria

Oslo Universitetssykehus-Rikshospitalet; 🇳🇴 Oslo, Norway

Ankara City Hospital; 🇹🇷 Ankara, Turkey

Freeman Hospital; 🇬🇧 Newcastle, United Kingdom

Hospital Universitario da Coruña; 🇪🇸 A Coruña, Spain

Hospital Universitari de Bellvitge; 🇪🇸 Barcelona, Spain

Royal Brompton & Harefield NHS Foundation Trust - Harefield Hospital; 🇬🇧 Harefield, United Kingdom

UZ Leuven - Campus Gasthuisberg; 🇧🇪 Leuven, Belgium

Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum; 🇩🇪 Bad Oeynhausen, Germany

Herzzentrum Leipzig GmbH; 🇩🇪 Leipzig, Germany

Aarhus Universitetshospital; 🇩🇰 Aarhus, Denmark

Medizinische Hochschule Hannover; 🇩🇪 Hannover, Germany

Azienda Ospedaliero Universitaria S. Orsola Malpighi Bologna; 🇮🇹 Bologna, Italy

ISMETT; 🇮🇹 Palermo, Italy

Otto von Guericke Universitat - Universitätsklinikum Magdeburg; 🇩🇪 Magdeburg, Germany

Ospedale San Raffaele; 🇮🇹 Milano, 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

Instytut Kardiologii; 🇵🇱 Warsaw, Poland

Klinicki Centar Srbije; 🇷🇸 Belgrade, Serbia

Ege Universitesi Tip Fakultesi Hastanesi; 🇹🇷 İzmir, Turkey

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Schuechtermann Klinik; 🇩🇪 Bad Rothenfelde, Germany

Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen; 🇩🇪 Tübingen, Germany

Universitätsklinikum Düsseldorf; 🇩🇪 Duesseldorf, Germany

Deutsches Herzzentrum Berlin; 🇩🇪 Berlin, Germany

UniversitätsSpital Zürich; 🇨🇭 Zürich, Switzerland

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands