Destination Therapy Post Approval Study (DT PAS)
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|ClinicalTrials.gov Identifier: NCT03681210|
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : December 22, 2020
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.
|Condition or disease||Intervention/treatment|
|Chronic Heart Failure||Device: HeartWare Ventricular Assist Device|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||5 Years|
|Official Title:||Destination Therapy Post Approval Study|
|Actual Study Start Date :||October 31, 2018|
|Estimated Primary Completion Date :||April 2023|
|Estimated Study Completion Date :||April 2026|
Patients implanted with HVAD System
Patients intended to be implanted with a HVAD for use as destination therapy are eligible for enrollment into the DT PAS and must be consented for the study prior to the HVAD implant.
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).
Other Name: HVAD
- 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.
- Rate of stroke [ Time Frame: Implant to 2 years ]The rate of stroke on device will be analyzed using Kaplan-Meier methods.
- Rate of late stroke [ Time Frame: 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 [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681210
|Contact: DT PAS Managerfirstname.lastname@example.org|