Medtronic HAMMOCK Post Approval Study

Heart Valve Diseases Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03139721
• Other study ID #: 1024882DOC
• Status: Completed
• Start date: June 19, 2017
• Est. completion date: June 21, 2021

Study information

• Verified date: October 2021
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: June 21, 2021
• Est. primary completion date: May 17, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Valve Diseases

Intervention

Device:
• Mosaic model 305, model 310, and ultra model 305
Aortic or mitral valve replacement

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Cardiovascular

Countries where clinical trial is conducted

United States,  Germany,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deaths, re-interventions, explants	Related to valve	1 year post implant
Secondary	Clinically acceptable hemodynamic performance	Related to valve	(at discharge (or 30 days), 1 year and annually thereafter through 3 years)
Secondary	New York Heart Association Functional Classification	Related to valve	1 year and annually thereafter through 3 years