This study is in progress, not accepting new patients

Destination Therapy Post Approval Study

a study on Heart Failure

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

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.

Details

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.

Keywords

Chronic Heart Failure, Heart Failure, Heart Diseases, Cardiovascular Diseases, HeartWare Ventricular Assist Device

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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.

Locations

  • University of California San Diego
    San Diego California 92103 United States
  • Stanford University Hospital
    Stanford California 94305-5330 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
ID
NCT03681210
Study Type
Observational [Patient Registry]
Participants
About 300 people participating
Last Updated