Status:
COMPLETED
Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials
Lead Sponsor:
Medtronic Cardiac Rhythm and Heart Failure
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- The patient is unwilling or unable to comply with trial requirements.
- The patient did not sign the informed consent.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2018
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT01832610
Start Date
January 1 2013
End Date
March 1 2018
Last Update
July 11 2019
Active Locations (25)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305
2
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
3
University of Florida - Gainesville
Gainesville, Florida, United States, 32610
4
University of Miami / Jackson Memorial Hospital
Miami, Florida, United States, 33136