Chronic Heart FailureNCT04065997
Apogee International
An observational study of Chronic Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 31 sites in 17 countries.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure
- What is being tested?
- HeartWare Ventricular Assist Device
- Type of treatment
- Medical device
- How many people
- 147 participants
- Where
- 31 sitesin 17 countries
- Study dates
- 6 Sep 2019to 26 Jul 2021
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
31 sites in 17 countries.
31 sites in 17 countries
Germany9 sites
Herz- und Diabeteszentrum NRW - Ruhr-Universität Bochum
Bad Oeynhausen
Schuechtermann Klinik
Bad Rothenfelde
Deutsches Herzzentrum Berlin
Berlin
Universitätsklinikum Düsseldorf
Düsseldorf
Universitätsklinikum Hamburg-Eppendorf
Hamburg
Medizinische Hochschule Hannover
Hanover
Herzzentrum Leipzig GmbH
Leipzig
Otto von Guericke Universitat - Universitätsklinikum Magdeburg
Magdeburg
Eberhard Karls Universität Tübingen - Universitätsklinikum Tübingen
Tübingen
Italy3 sites
Azienda Ospedaliero Universitaria S. Orsola Malpighi Bologna
Bologna
Ospedale San Raffaele
Milan
ISMETT
Palermo
Netherlands2 sites
Leiden Universitair Medisch Centrum (LUMC)
Leiden
University Medical Center Utrecht
Utrecht
Spain2 sites
Hospital Universitario da Coruña
A Coruña
Hospital Universitari de Bellvitge
Barcelona
Turkey (Türkiye)2 sites
Ankara City Hospital
Ankara
Ege Universitesi Tip Fakultesi Hastanesi
Izmir
United Kingdom2 sites
Royal Brompton & Harefield NHS Foundation Trust - Harefield Hospital
Harefield
Freeman Hospital
Newcastle
About this study
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.
Read the 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:
- Logfile Download;
- Anti-coagulation / Anti-platelet Management;
- Blood Pressure (BP) Management;
- Acoustic Spectrum Analysis;
- Infection Control
- Conditions
- Chronic Heart Failure
- Being tested
- HeartWare Ventricular Assist Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeartWare Ventricular Assist DeviceDevice
Also called HVAD
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: HeartWare Ventricular Assist Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse events
Major adverse events are defined to be occurrence of major infection, major bleeding, device malfunction, stroke or death.
Measured: Implant to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2019
- Study start6 Sep 2019
- Primary completion26 Jul 2021
- Study completion26 Jul 2021
Why it stopped: Due to Medtronic's decisions to stop sales and distribution of the HVAD System and subsequent stop of study enrollments, limited data will be available. Therefore it is not expected to provide new insights.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 147 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04065997
- Sponsor's protocol ID
- Apogee International
- Status last verified
- Jul 2021
- First submitted
- 21 Aug 2019
- Last updated
- 3 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Apogee International
- ClinicalTrials.gov ID
- NCT04065997
- Acronym / sponsor ID
- Apogee International
- Conditions
- Chronic Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Due to Medtronic's decisions to stop sales and distribution of the HVAD System and subsequent stop of study enrollments, limited data will be available. Therefore it is not expected to provide new insights.
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- 6 Sep 2019 (actual)
- Primary completion
- 26 Jul 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 22 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Logfile Download;
- Anti-coagulation / Anti-platelet Management;
- Blood Pressure (BP) Management;
- Acoustic Spectrum Analysis;
- Infection Control
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients implanted with HVAD System | – | Device: HeartWare Ventricular Assist DevicePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HeartWare Ventricular Assist DeviceAlso: HVADThe 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). | Device | Patients implanted with HVAD System |
Primary outcome
Major adverse events
Time frame: Implant to 12 months
Major adverse events are defined to be occurrence of major infection, major bleeding, device malfunction, stroke or death.
Results and safety
The study was stopped early (reason given: Due to Medtronic's decisions to stop sales and distribution of the HVAD System and subsequent stop of study enrollments, limited data will be available. Therefore it is not expected to provide new insights.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Heart Failure, run by Medtronic Cardiac Rhythm and Heart Failure at 31 sites in 17 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Germany, Italy, Netherlands, Spain, Turkey (Türkiye) and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to Medtronic's decisions to stop sales and distribution of the HVAD System and subsequent stop of study enrollments, limited data will be available. Therefore it is not expected to provide new insights.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse events (time frame: Implant to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.