Destination Therapy Post Approval Study
(DT PAS Trial)

Recruiting in Palo Alto (17 mi)

+46 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Medtronic Cardiac Rhythm and Heart Failure

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

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

Treatment Details

Interventions

HeartWare Ventricular Assist Device (Ventricular Assist Device)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Patients implanted with HVAD SystemExperimental Treatment1 Intervention

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.