Heart Failure Clinical Trial
Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials
Summary
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.
Full Description
Patients who participated in prior trials will be approached for this PAS as follows:
Patients who are on continued HeartWare® System support, (original or exchange device)
Patients who have been explanted for transplant or recovery and have not yet completed 6 months of follow-up
Patients who participated in prior trials who will not be approached to participate in this follow-up study include:
• Patients who have been explanted for transplant or recovery and have completed at least 6 months of follow-up (documented in the prior IDE trial).
No new patients are being screened or implanted with the HeartWare® System for this trial, it is a follow-up trial only.
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
The patient is unwilling or unable to comply with trial requirements.
The patient did not sign the informed consent.
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There are 25 Locations for this study
Stanford California, 94305, United States
Washington District of Columbia, 20010, United States
Gainesville Florida, 32610, United States
Miami Florida, 33136, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60611, United States
Chicago Illinois, 60637, United States
Oak Lawn Illinois, 60453, United States
Indianapolis Indiana, 46202, United States
Louisville Kentucky, 40202, United States
Boston Massachusetts, 02111, United States
Ann Arbor Michigan, 48109, United States
Detroit Michigan, 48202, United States
Minneapolis Minnesota, 55455, United States
Saint Louis Missouri, 63110, United States
Bronx New York, 10467, United States
Durham North Carolina, 27710, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43210, United States
Hershey Pennsylvania, 17033, United States
Philadelphia Pennsylvania, 19104, United States
Pittsburgh Pennsylvania, 15213, United States
Dallas Texas, 75390, United States
Houston Texas, 77030, United States
Spokane Washington, 99204, United States
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