Medtronic HAMMOCK Post Approval Study

NCT03139721 | Completed Results FDA Device

• 1 other identifier: 1024882DOC
• Study Type: observational
• Target: 122
• Locations: 3 countries
• Sites: 7

Brief Summary

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

Conditions

Heart Valve Diseases

Outcome Measures

Primary Outcomes (2)

• Number of Deaths, Reinterventions, or Explants

  Number of deaths, reinterventions, or explants related to the valve

  1-year post implant

• Number of Deaths, Reinterventions, or Explants

  Number of deaths, reinterventions, or explants related to the valve

  3-years post implant

Secondary Outcomes (22)

• Mean Gradient (mmHg)

  1-year post implant

• Peak Gradient (mmHg)

  1-year post implant

• Effective Orifice Area (EOA)

  1-year post implant

• Effective Orifice Area Index (EOAi)

  1-year post implant

• Cardiac Output

  1-year post implant

Study Arms (1)

Primary cohort

Subjects requiring aortic or mitral valve replacement

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

Interventions

Mosaic model 305, model 310, and ultra model 305 DEVICE

Aortic or mitral valve replacement

Also known as: Hancock II model T505, model T510, and ultra model T505

Primary cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects requiring aortic or mitral valve replacement of the native valve.

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.

Sponsors & Collaborators

• Medtronic Cardiac Surgery: lead

Study Sites (7)

Franciscan Saint Francis Health

Indianapolis, Indiana, 46237, United States

Location

ProMedica Toledo Hospital

Toledo, Ohio, 43606, United States

Location

Saint Joseph Medical Center

Tacoma, Washington, 98405, United States

Location

Bellin Memorial Hospital

Green Bay, Wisconsin, 54301, United States

Location

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Deutsches Herzzentrum München Klinik an der TU München

München, 80636, Germany

Location

Institute of Cardiology in Warsaw

Warsaw, Poland

Location

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Jessica Halverson, Clinical Research Director
• Organization: Medtronic

rs.CSHHAMMOCKPAS@medtronic.com

763-514-9756

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: May 4, 2017
• Study Start: June 19, 2017
• Primary Completion: May 17, 2019
• Study Completion: June 21, 2021
• Last Updated: August 23, 2024
• Results First Posted: August 23, 2024

Record last verified: 2024-08

Locations

DE (2); PL (1); US (4)