Destination Therapy Post Approval Study (DT PAS)

Medtronic

Status: Active, not recruiting

Conditions: Chronic Heart Failure

Treatments: Device: HeartWare Ventricular Assist Device

Study type: Observational

Funder types: Industry

Identifiers

NCT03681210

DT PAS

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

Patients implanted with HVAD System

Description:

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.

Treatment:

Device: HeartWare Ventricular Assist Device