HW006 LATERAL Thoracotomy (HVAD)

Medtronic

Status

Completed

Conditions

Left Sided Heart Failure

Treatments

Device: HeartWare HVAD

Procedure: Thoracotomy

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT02268942

HW006 Thoracotomy

Details and patient eligibility

About

This is a prospective, multi-center,single-arm study that will evaluate the thoracotomy implant technique in up to 145 subjects implanted via thoracotomy with the HeartWare HVAD System and enrolled in the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs®) protocol and database.

All participating centers are current INTERMACS® sites in good standing and follow the INTERMACS® protocol and procedures.

Enrollment

144 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Must be ≥19 years of age at time of informed consent to participate in the Intermacs® registry.
Subject receives a HeartWare HVAD (The device should be the subject's first VAD implant).
Subject signed an Intermacs® informed consent if required by local IRB policy.
Subject signed a HeartWare informed consent.

Exclusion criteria

Subject is incarcerated (prisoner).
Subject did not sign the informed consent at sites where waiver of consent was not granted.
Body Surface Area (BSA) < 1.2 m^2.
Prior cardiac transplant or cardiomyoplasty.
Subject is receiving a BiVAD.
Subject is receiving the device as an RVAD.
Subject data is generated from non- Intermacs® centers.
Pediatric subjects (< 19 years of age).
Subjects who receive a temporary LVAD
Subjects whose device strategy is listed as "Destination Therapy" at the time of implant.
Severe Right Heart failure
Aortic insufficiency or mechanical aortic valve.
Planned concomitant procedure (e.g.valve repair or replacement, CABG, septal defect repair).
Known LV Thrombus.