HW006 LATERAL Thoracotomy

Study Overview
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Brief Summary
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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.

Official Title
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A Prospective, Single-Arm, Multi-Center Study in Collaboration With INTERMACS to Evaluate the Thoracotomy Implant Technique of the HeartWare™ HVAD™ System in Patients With Advanced Heart Failure

Conditions
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Left Sided Heart Failure

Intervention / Treatment
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* Device: HeartWare HVAD
* Procedure: Thoracotomy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HeartWare HVAD via Thoracotomy<br>HeartWare HVAD implanted via thoracotomy | Device: HeartWare HVAD<br>* Implant of HeartWare HVAD via thoracotomy implant technique<br>Procedure: Thoracotomy<br>* Thoracotomy implant technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months | Alive on the originally implanted device at six months, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or Transplanted by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event); or Explanted for recovery by Month 6, and the subject has not had a stroke with a modified Rankin Scale ≥ 4 (assessed ≥ three months post-stroke event). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Length of Initial Hospital Stay | Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time | Initial Hospital Stay |