HW006 LATERAL Thoracotomy

Completed · Not applicable

Conditions studied: Left Sided Heart Failure

In brief

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.

Key facts

Study ID

NCT02268942

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

144

Starts

2014-11-01

Expected to finish

2018-10-01

Last updated by the study team

2019-12-02

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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