Apogee, A HeartWare HVAD Destination Product Surveillance Registry (PSR) Platform

Medtronic

Status: Completed

Conditions: Chronic Heart Failure

Treatments: Device: HeartWare Ventricular Assist Device

Study type: Observational

Funder types: Industry

Identifiers

NCT03697980

Apogee

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• There are no exclusion criteria unique to Apogee.

Trial design

136 participants in 1 patient group

HVAD Left Ventricular Assist Device

Description:

Device: HeartWare Ventricular Assist Device Other Names: HVAD 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).

Treatment:

Device: HeartWare Ventricular Assist Device