Medtronic HAMMOCK Post Approval Study

Completed

Conditions studied: Heart Valve Diseases

In brief

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

Key facts

Study ID

NCT03139721

Run by

Medtronic Cardiac Surgery

People needed

122

Starts

2017-06-19

Expected to finish

2021-06-21

Last updated by the study team

2024-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Franciscan Saint Francis Health — Indianapolis, Indiana, United States
• ProMedica Toledo Hospital — Toledo, Ohio, United States
• Saint Joseph Medical Center — Tacoma, Washington, United States
• Bellin Memorial Hospital — Green Bay, Wisconsin, United States
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany
• Deutsches Herzzentrum München Klinik an der TU München — München, Germany
• Institute of Cardiology in Warsaw — Warsaw, Poland

Full record on ClinicalTrials.gov

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