Medtronic HAMMOCK Post Approval Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-19

Study Completion Date

2021-06-21

Brief Summary

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

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Detailed Description

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Conditions

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Heart Valve Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Primary cohort

Subjects requiring aortic or mitral valve replacement

Mosaic model 305, model 310, and ultra model 305

Intervention Type DEVICE

Aortic or mitral valve replacement

Interventions

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Mosaic model 305, model 310, and ultra model 305

Aortic or mitral valve replacement

Intervention Type DEVICE

Other Intervention Names

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Hancock II model T505, model T510, and ultra model T505

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No