Destination Therapy Post Approval Study (DT PAS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03681210|
Recruitment Status : Recruiting
First Posted : September 24, 2018
Last Update Posted : January 3, 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 :||November 2025|
|Estimated Study Completion Date :||November 2025|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03681210
|Contact: DT PAS Managerfirstname.lastname@example.org|