Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/30/2018 |
| Start Date: | January 2013 |
| End Date: | March 2018 |
A Multi Center, Post Approval Study Providing Continued Evaluation and Follow-up on Patients Who Received a HeartWare® Ventricular Assist System During IDE Trials for the Treatment of Advanced Heart Failure
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.
Assist System receives PMA approval for the indicated use as a bridge to cardiac
transplantation.
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.
- 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.
Inclusion Criteria:
1. The patient has participated in a prior HeartWare trial under IDE G070199.
2. The patient was implanted with the HeartWare® Ventricular Assist System and was an
active patient in the prior trial.
3. The patient has signed informed consent for participation in the study.
Exclusion Criteria:
1. The patient is unwilling or unable to comply with trial requirements.
2. The patient did not sign the informed consent.
We found this trial at
25
sites
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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University of Chicago One of the world's premier academic and research institutions, the University of...
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University of Florida Gainesville UF has a long history of established programs in international education,...
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Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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3400 Spruce St
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
(215) 662-4000
Hospital of the University of Pennsylvania The Hospital of the University of Pennsylvania (HUP) is...
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Stanford University School of Medicine Vast in both its physical scale and its impact on...
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Advocate Christ Medical Center Advocate Health Care, named among the nation
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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110 Irving St NW
Washington, District of Columbia 20010
Washington, District of Columbia 20010
(202) 877-7000
Washington Hosp Ctr MedStar Washington Hospital Center is a not-for-profit, 926-bed, major teaching and research...
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