Trials / Terminated
TerminatedNCT04065997
Apogee International
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 147 (actual)
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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). |
Timeline
- Start date
- 2019-09-06
- Primary completion
- 2021-07-26
- Completion
- 2021-07-26
- First posted
- 2019-08-22
- Last updated
- 2021-08-03
Locations
31 sites across 17 countries: Australia, Austria, Belgium, Denmark, Finland, Germany, Italy, Kazakhstan, Lebanon, Netherlands, Norway, Poland, Serbia, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04065997. Inclusion in this directory is not an endorsement.