Medtronic HAMMOCK Post Approval Study

Medtronic

Status: Completed

Conditions: Heart Valve Diseases

Treatments: Device: Mosaic model 305, model 310, and ultra model 305

Study type: Observational

Funder types: Industry

Identifiers

NCT03139721

1024882DOC

Details and patient eligibility

About

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

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

122 participants in 1 patient group

Primary cohort

Description:

Subjects requiring aortic or mitral valve replacement

Treatment:

Device: Mosaic model 305, model 310, and ultra model 305