Trial Review

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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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04065997