Chronic Heart Failure
Conditions
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: 1. Logfile Download; 2. Anti-coagulation / Anti-platelet Management; 3. Blood Pressure (BP) Management; 4. Acoustic Spectrum Analysis; 5. Infection Control
Interventions
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).
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Major adverse events | Implant to 12 months | Major adverse events are defined to be occurrence of major infection, major bleeding, device malfunction, stroke or death. |
Countries
Australia, Austria, Belgium, Denmark, Finland, Germany, Italy, Kazakhstan, Lebanon, Netherlands, Norway, Poland, Serbia, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Outcome results
None listed