HW006 LATERAL Thoracotomy

Medtronic Cardiac Rhythm and Heart Failure144 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

144

Conditions

Left Sided Heart Failure

Interventions

HeartWare HVADDEVICE

Implant of HeartWare HVAD via thoracotomy implant technique

ThoracotomyPROCEDURE

Thoracotomy implant technique

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Must be ≥19 years of age at time of informed consent to participate in the Intermacs® registry. 2. Subject receives a HeartWare HVAD (The device should be the subject's first VAD implant). 3. Subject signed an Intermacs® informed consent if required by local IRB policy. 4. Subject signed a HeartWare informed consent. Exclusion Criteria: 1. Subject is incarcerated (prisoner). 2. Subject did not sign the informed consent at sites where waiver of consent was not granted. 3. Body Surface Area (BSA) \< 1.2 m\^2. 4. Prior cardiac transplant or cardiomyoplasty. 5. Subject is receiving a BiVAD. 6. Subject is receiving the device as an RVAD. 7. Subject data is generated from non- Intermacs® centers. 8. Pediatric subjects (\< 19 years of age). 9. Subjects who receive a temporary LVAD 10. Subjects whose device strategy is listed as "Destination Therapy" at the time of implant. 11. Severe Right Heart failure 12. Aortic insufficiency or mechanical aortic valve. 13. Planned concomitant procedure (e.g.valve repair or replacement, CABG, septal defect repair). 14. Known LV Thrombus.

Locations (26)

Outcomes

Primary Outcomes

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).

Time frame: 6 months

Secondary Outcomes

Mean Length of Initial Hospital Stay

Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time

Time frame: Initial Hospital Stay

Data from ClinicalTrials.gov

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