NCT03681210

Destination Therapy Post Approval Study

Official Title:

Destination Therapy Post Approval Study

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.

Eligibility

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.

Disease(s) and\or Condition(s)

Chronic Heart Failure

Primary Purpose
Intervention/Treatment
    • Type: DEVICE
    • Name: HeartWare Ventricular Assist Device
    • Description: 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).
    • Arm Group Labels: Patients implanted with HVAD System
Sponsor
  • Medtronic Cardiac Rhythm and Heart Failure