Apogee International

Chronic Heart Failure Clinical Trial

Official title:

Apogee International

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04065997
• Other study ID #: Apogee International
• Status: Terminated
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Heart Failure
• Heart Failure

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