Apogee International
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 147
- Locations
- 31
- Primary Endpoint
- Major adverse events
Study Overview
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.
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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported