Summary

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

Description

Summary

Medtronic is sponsoring the Apogee study to further enhance scientific understanding of the implant procedure, optimized blood pressure management, and anticoagulation/ antiplatelet therapy in patients receiving a Medtronic HeartWare™ Ventricular Assist Device (HVAD™) for destination therapy. The Apogee study is conducted within Medtronic's Product Surveillance Platform.

Details

The Apogee study is a prospective, observational, post-market, on-label, multi-site study in Destination Therapy patients. Patients participating in the Medtronic Destination Therapy (DT) Post Approval Study (PAS) (NCT03681210) are eligible for participation in Apogee. Patients enrolled in Apogee will be followed under the Apogee study for one-year post-implant. After participation in Apogee ends, patients will remain enrolled in DT PAS and will continue to be followed as outlined in the DT PAS protocol. The total estimated study duration is 33 months.

Keywords

Chronic Heart Failure Heart Failure HeartWare Ventricular Assist Device HVAD

Eligibility

You can join if…

Open to people ages 18 years and up

  • Subjects consented to participate in DT PAS are eligible for participation in Apogee.

You CAN'T join if...

  • There are no exclusion criteria unique to Apogee.

Locations

  • University of California San Francisco Medical Center accepting new patients
    San Francisco California 94143 United States
  • Stanford University Hospital accepting new patients
    Stanford California 94305-5330 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Medtronic Cardiac Rhythm and Heart Failure
ID
NCT03697980
Study Type
Observational [Patient Registry]
Last Updated