Chronic Heart Failure
Conditions
Keywords
Heart Failure, Heart Diseases, Cardiovascular Diseases
Brief summary
Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in real-world clinical practice. The Destination Therapy Post Approval Study (DT PAS) is conducted within Medtronic's Product Surveillance Platform.
Detailed description
The HeartWare Destination Therapy (DT) Post Approval Study (PAS) is a prospective, observational, multi-site study. Enrollment into the DT PAS will be comprised of newly enrolled, commercial use DT patients with the HeartWare Ventricular Assist Device System (HVAD System). Patients enrolled in DT PAS will be followed for 5 years post-implant or until study closure, patient death, patient exit from the PAS (i.e., withdrawal of consent), or patient has HVAD device removed without replacement (i.e., transplant, recovery) or device is exchanged for non-HVAD. The total estimated study duration is approximately 7 years.
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 * Patient is intended to receive or be treated with a HeartWare HVAD System for use as destination therapy * Patient is consented prior to the HVAD implant procedure
Exclusion criteria
* Patient who is, or is expected to be inaccessible for follow-up * Patient with
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term complication free survival | Implant to 2 years | Complications include death, disabling stroke, or device malfunction or failure requiring exchange, explantation or urgent transplantation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of stroke | Implant to 2 years | The rate of stroke on device will be analyzed using Kaplan-Meier methods. |
| Rate of late stroke | 2 years post-implant to 5 years | The rate of late stroke on device will be analyzed using Kaplan-Meier methods for those surviving stroke-free for 24 months post-implant. |
| Stroke severity | Occurrence of stroke to 24 weeks post-stroke | Modified Rankin Scale (mRS) scores will be collected at the time associated with stroke on device and at 12 and 24 weeks post-stroke. The distribution of mRS scores for all strokes occurring in the study will be presented, separating stroke occurring prior to 24 months post-implant and those occurring greater than 24 months post-implant. |
Countries
United States
Outcome results
None listed