Destination Therapy Post Approval Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Heart Failure
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Enrollment
- 300
- Locations
- 47
- Primary Endpoint
- Long-term complication free survival
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
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 exclusion criteria required by local law
- •Patient is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound results (i.e., no required intervention that could affect interpretation of all-around product safety and or effectiveness)
- •Patient less than 18 years of age.
- •Patient with previous support by long-term mechanical circulatory support (MCS), not including temporary mechanical circulatory support.
Outcomes
Primary Outcomes
Long-term complication free survival
Time Frame: Implant to 2 years
Complications include death, disabling stroke, or device malfunction or failure requiring exchange, explantation or urgent transplantation.
Secondary Outcomes
- Stroke severity(Occurrence of stroke to 24 weeks post-stroke)
- Rate of stroke(Implant to 2 years)
- Rate of late stroke(2 years post-implant to 5 years)