Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials

Completed

Conditions studied: Heart Failure

In brief

Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.

Key facts

Study ID

NCT01832610

Run by

Medtronic Cardiac Rhythm and Heart Failure

People needed

101

Starts

2013-01-01

Expected to finish

2018-03-01

Last updated by the study team

2019-07-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient has participated in a prior HeartWare trial under IDE G070199.
• The patient was implanted with the HeartWare® Ventricular Assist System and was an active patient in the prior trial.
• The patient has signed informed consent for participation in the study.

You may not qualify if…

• The patient is unwilling or unable to comply with trial requirements.
• The patient did not sign the informed consent.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• University of Florida - Gainesville — Gainesville, Florida, United States
• University of Miami / Jackson Memorial Hospital — Miami, Florida, United States
• The Emory Clinic Inc. — Atlanta, Georgia, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• University of Chicago — Chicago, Illinois, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• IU Health Methodist — Indianapolis, Indiana, United States
• Jewish Hospital - Rudd Heart and Lung Institute — Louisville, Kentucky, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• University of Michigan Hospital — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Washington University / Barnes Jewish Hospital — St Louis, Missouri, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• University of Texas - South Western — Dallas, Texas, United States
• Texas Heart Institute — Houston, Texas, United States
• Northwest Cardiothoracic &Transplant Surgeons — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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