CompletedNot Applicable

Medtronic HAMMOCK Post Approval Study

United States, Germany122 participantsStarted 2017-06-19

Plain-language summary

This study is being conducted to satisfy the post-CE approval requirement.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Subjects who require aortic or mitral valve replacement of their native valve.
✓. Subject is geographically stable and willing to return to the implanting site for all follow-up visits.
✓. Subject is of legal age to provide informed consent in the country where they enroll in the study.
✓. 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.

✕. Subject requires concomitant replacement of the aortic and mitral valves.
✕. Subject requires a replacement of a previously implanted prosthetic aortic or mitral valve.
✕. Subject requires a Bentall procedure for replacement of aortic valve or aortic root.

Number of Deaths, Reinterventions, or Explants

Timeframe: 1-year post implant

Number of Deaths, Reinterventions, or Explants

Timeframe: 3-years post implant

NCT IDNCT03139721

SponsorMedtronic Cardiac Surgery

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2019-05-17

Results submitted2022-04-14