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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04065997




Registration number
NCT04065997
Ethics application status
Date submitted
21/08/2019
Date registered
22/08/2019
Date last updated
3/08/2021

Titles & IDs
Public title
Apogee International
Scientific title
Apogee International
Secondary ID [1] 0 0
Apogee International
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - HeartWare Ventricular Assist Device

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.


Treatment: Devices: 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).
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Major adverse events
Timepoint [1] 0 0
Implant to 12 months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
26/07/2021
Sample size
Target
Accrual to date
Final
147
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
St. Vincents Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Belgium
State/province [2] 0 0
Leuven
Country [3] 0 0
Denmark
State/province [3] 0 0
Aarhus
Country [4] 0 0
Finland
State/province [4] 0 0
Helsinki
Country [5] 0 0
Germany
State/province [5] 0 0
Bad Oeynhausen
Country [6] 0 0
Germany
State/province [6] 0 0
Bad Rothenfelde
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Germany
State/province [8] 0 0
Duesseldorf
Country [9] 0 0
Germany
State/province [9] 0 0
Hamburg
Country [10] 0 0
Germany
State/province [10] 0 0
Hannover
Country [11] 0 0
Germany
State/province [11] 0 0
Leipzig
Country [12] 0 0
Germany
State/province [12] 0 0
Magdeburg
Country [13] 0 0
Germany
State/province [13] 0 0
Tübingen
Country [14] 0 0
Italy
State/province [14] 0 0
Bologna
Country [15] 0 0
Italy
State/province [15] 0 0
Milano
Country [16] 0 0
Italy
State/province [16] 0 0
Palermo
Country [17] 0 0
Kazakhstan
State/province [17] 0 0
Astana
Country [18] 0 0
Lebanon
State/province [18] 0 0
Beirut
Country [19] 0 0
Netherlands
State/province [19] 0 0
Leiden
Country [20] 0 0
Netherlands
State/province [20] 0 0
Utrecht
Country [21] 0 0
Norway
State/province [21] 0 0
Oslo
Country [22] 0 0
Poland
State/province [22] 0 0
Warsaw
Country [23] 0 0
Serbia
State/province [23] 0 0
Belgrade
Country [24] 0 0
Spain
State/province [24] 0 0
A Coruña
Country [25] 0 0
Spain
State/province [25] 0 0
Barcelona
Country [26] 0 0
Switzerland
State/province [26] 0 0
Zürich
Country [27] 0 0
Turkey
State/province [27] 0 0
Ankara
Country [28] 0 0
Turkey
State/province [28] 0 0
Izmir
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Harefield
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Newcastle

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Medtronic Cardiac Rhythm and Heart Failure
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT04065997
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04065997