Status:
TERMINATED
Apogee International
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Chronic Heart Failure
Eligibility:
All Genders
18+ years
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 ...
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 Internati...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 6 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 26 2021
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT04065997
Start Date
September 6 2019
End Date
July 26 2021
Last Update
August 3 2021
Active Locations (31)
Enter a location and click search to find clinical trials sorted by distance.
1
St. Vincents Hospital
Sydney, Australia
2
Medical University of Vienna
Vienna, Austria
3
UZ Leuven - Campus Gasthuisberg
Leuven, Belgium
4
Aarhus Universitetshospital
Aarhus, Denmark