Medtronic HAMMOCK Post Approval Study
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/18/2018 |
| Start Date: | June 19, 2017 |
| End Date: | June 30, 2021 |
Medtronic Hancock II® and Mosaic Mitral and Aortic Valves: A Study to Observe the Effects of the Stent Material Change to PEEK Post Approval Study (HAMMOCK PAS)
This study is being conducted to satisfy the post-CE approval requirement.
Inclusion Criteria:
1. Subjects who require aortic or mitral valve replacement of their native valve.
2. Subject is geographically stable and willing to return to the implanting site for all
follow-up visits.
3. Subject is of legal age to provide informed consent in the country where they enroll
in the study.
4. Subject has been adequately informed of risks and requirements of the study and is
willing and able to provide informed consent for participation in the clinical study.
Exclusion Criteria:
1. Subject requires concomitant replacement of the aortic and mitral valves.
2. Subject requires a replacement of a previously implanted prosthetic aortic or mitral
valve.
3. Subject requires a Bentall procedure for replacement of aortic valve or aortic root.
We found this trial at
5
sites
Saint Joseph Medical Center St. Joseph Medical Center is a 361-bed regional medical center that...
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Green Bay, Wisconsin 54301
Principal Investigator: Steven Gerndt, MD
Phone: 920-621-0047
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Hamburg, 20246
Principal Investigator: Lenard Conradi, MD
Phone: 49 (0)40 7410-57503
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