Apogee International

NCT04065997 | Terminated FDA Device

• 1 other identifier: Apogee International
• Study Type: observational
• Target: 147
• Locations: 16 countries
• Sites: 30

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.

Conditions

Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

HeartWare Ventricular Assist Device 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).

Also known as: HVAD

Patients implanted with HVAD System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (31)

St. Vincents Hospital

Sydney, Australia

Location

Medical University of Vienna

Vienna, Austria

Location

UZ Leuven - Campus Gasthuisberg

Leuven, Belgium

Location

Aarhus Universitetshospital

Aarhus, Denmark

Location

Helsinki University Hospital

Helsinki, Finland

Location

Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum

Bad Oeynhausen, Germany

Location

Schuechtermann Klinik

Bad Rothenfelde, Germany

Location

Deutsches Herzzentrum Berlin

Berlin, Germany

Location

Universitätsklinikum Düsseldorf

Düsseldorf, Germany

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, Germany

Location

Medizinische Hochschule Hannover

Hanover, Germany

Location

Herzzentrum Leipzig GmbH

Leipzig, Germany

Location

Otto von Guericke Universitat - Universitätsklinikum Magdeburg

Magdeburg, Germany

Location

Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen

Tübingen, Germany

Location

Azienda Ospedaliero Universitaria S. Orsola Malpighi Bologna

Bologna, Italy

Location

Ospedale San Raffaele

Milan, Italy

Location

ISMETT

Palermo, Italy

Location

National Research Cardiac Surgery Center

Astana, Kazakhstan

Location

Al Rassoul Al Azam Hospital - Beirut Cardiac Institute

Beirut, Lebanon

Location

Leiden Universitair Medisch Centrum (LUMC)

Leiden, Netherlands

Location

University Medical Center Utrecht

Utrecht, Netherlands

Location

Oslo Universitetssykehus-Rikshospitalet

Oslo, Norway

Location

Instytut Kardiologii

Warsaw, Poland

Location

Klinicki Centar Srbije

Belgrade, Serbia

Location

Hospital Universitario da Coruña

A Coruña, Spain

Location

Hospital Universitari de Bellvitge

Barcelona, Spain

Location

UniversitätsSpital Zürich

Zurich, Switzerland

Location

Ankara City Hospital

Ankara, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, Turkey (Türkiye)

Location

Royal Brompton & Harefield NHS Foundation Trust - Harefield Hospital

Harefield, United Kingdom

Location

Freeman Hospital

Newcastle, United Kingdom

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 22, 2019
• Study Start: September 6, 2019
• Primary Completion: July 26, 2021
• Study Completion: July 26, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07

Locations

DK (1); DE (9); IT (3); KA (1); CH (1); NL (2); LE (1); GB (2); AU (1); SE (1); ES (2); PL (1); NO (1); TU (2); BE (1); FI (1)