HW006 LATERAL Thoracotomy

Not Applicable

Completed

Conditions: Left Sided Heart Failure

Interventions: Device: HeartWare HVAD
Procedure: Thoracotomy

Registration Number: NCT02268942

Lead Sponsor: Medtronic Cardiac Rhythm and Heart Failure

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 144

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HeartWare HVAD via Thoracotomy	Thoracotomy	HeartWare HVAD implanted via thoracotomy
HeartWare HVAD via Thoracotomy	HeartWare HVAD	HeartWare HVAD implanted via thoracotomy

Primary Outcome Measures

Name	Time	Method
Subject is Alive on Original Device, Transplanted, or Explanted for Recovery at 6 Months	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).

Secondary Outcome Measures

Name	Time	Method
Mean Length of Initial Hospital Stay	Initial Hospital Stay	Mean length of initial hospital stay including both acute care (ICU/CCU) and step-down Care time

Trial Locations

Locations (26): Hospital of the University of Pennsylvania
🇺🇸
Philadelphia, Pennsylvania, United States
Milton S. Hershey Medical Center
🇺🇸
Hershey, Pennsylvania, United States
Loyola University Medical Center
🇺🇸
Maywood, Illinois, United States
St. Paul's Hospital
🇨🇦
Vancouver, British Columbia, Canada
Inova Fairfax Hospital
🇺🇸
Falls Church, Virginia, United States
The University of Alabama
🇺🇸
Birmingham, Alabama, United States
UC San Diego
🇺🇸
San Diego, California, United States
UCSF Medical Center
🇺🇸
San Francisco, California, United States
Tampa Transplant Institute/Tampa General Hospital
🇺🇸
Tampa, Florida, United States
Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States
Tufts Medical Center
🇺🇸
Boston, Massachusetts, United States
IU Health Methodist
🇺🇸
Indianapolis, Indiana, United States
St. Vincent Hospital
🇺🇸
Indianapolis, Indiana, United States
University of Michigan Hospital
🇺🇸
Ann Arbor, Michigan, United States
Jewish Hospital - Rudd Heart and Lung Institute
🇺🇸
Louisville, Kentucky, United States
Mayo Rochester - St. Mary's Hospital
🇺🇸
Rochester, Minnesota, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
University of Washington Medical Center
🇺🇸
Seattle, Washington, United States
Stanford University School of Medicine
🇺🇸
Palo Alto, California, United States
Washington Hospital Center
🇺🇸
Washington, District of Columbia, United States
Allegheny General Hospital
🇺🇸
Pittsburgh, Pennsylvania, United States
St. Luke's Hospital of Kansas City
🇺🇸
Kansas City, Missouri, United States
Virginia Commonwealth University
🇺🇸
Richmond, Virginia, United States
John Ochsner Heart & Vascular Institute
🇺🇸
New Orleans, Louisiana, United States
Spectrum Health
🇺🇸
Grand Rapids, Michigan, United States