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Completed

NCT Number: NCT03139721

Medtronic HAMMOCK Post Approval Study

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

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Key information

Conditions

Heart Valve Diseases Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

Loading trial locations.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Mosaic model 305, model 310, and ultra model 305

Device

Aortic or mitral valve replacement

Other names: Hancock II model T505, model T510, and ultra model T505

Primary outcomes

  1. Number of Deaths, Reinterventions, or Explants

    Time frame: 1-year post implant

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

  2. Number of Deaths, Reinterventions, or Explants

    Time frame: 3-years post implant

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

Secondary outcomes

  1. Mean Gradient (mmHg)

    Time frame: 1-year post implant

    Measured by echocardiogram via Echo Core Lab

  2. Peak Gradient (mmHg)

    Time frame: 1-year post implant

    Measured by echocardiogram via Echo Core Lab

  3. Effective Orifice Area (EOA)

    Time frame: 1-year post implant

    Measured by echocardiogram via Echo Core Lab

  4. Effective Orifice Area Index (EOAi)

    Time frame: 1-year post implant

    EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area

  5. Cardiac Output

    Time frame: 1-year post implant

    Measured by echocardiogram via Echo Core Lab

  6. Cardiac Index

    Time frame: 1-year post implant

    Cardiac Output Measured by echocardiogram via Echo Core Lab/Body Surface Area

  7. Performance Index

    Time frame: 1-year post implant

    The performance index is a measure of how effectively the external dimension of the valve is used to provide forward flow, normalized to the valve size. It is defined as effective orifice area divided by the tissue annulus area, where the tissue annulus area is calculated from the prosthetic valve size.

  8. Transvalvular Regurgitation

    Time frame: 1-year post implant

    Measured by echocardiogram via Echo Core Lab

  9. Paravalvular Regurgitation

    Time frame: 1-year post implant

    Measured by echocardiogram via Echo Core Lab

  10. Total Regurgitation

    Time frame: 1-year post implant

    Measured by echocardiogram via Echo Core Lab

  11. New York Heart Association (NYHA) Classification

    Time frame: 1-year post implant

    Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.

    II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.

    III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.

    IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.

  12. Mean Gradient

    Time frame: 3-years post implant

    Measured by echocardiogram via Echo Core Lab

  13. Peak Gradient

    Time frame: 3-years post implant

    Measured by echocardiogram via Echo Core Lab

  14. Effective Orifice Area (EOA)

    Time frame: 3-years post implant

    Measured by echocardiogram via Echo Core Lab

  15. Effective Orifice Area Index (EOAi)

    Time frame: 3-years post implant

    EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area

  16. Cardiac Output

    Time frame: 3-years post implant

    Measure by echocardiogram via Echo Core Lab

  17. Cardiac Index

    Time frame: 3-years post implant

    Cardiac output measured by echocardiogram via Echo Core Lab/Body Surface Area

  18. Performance Index

    Time frame: 3-years post implant

    The performance index is a measure of how effectively the external dimension of the valve is used to provide forward flow, normalized to the valve size. It is defined as effective orifice area divided by the tissue annulus area, where the tissue annulus area is calculated from the prosthetic valve size.

  19. Transvalvular Regurgitation

    Time frame: 3-years post implant

    Measured by echocardiogram via Echo Core Lab

  20. Paravalvular Regurgitation

    Time frame: 3-years post implant

    Measured by echocardiogram via Echo Core Lab

  21. Total Regurgitation

    Time frame: 3-years post implant

    Measured by echocardiogram via Echo Core Lab

  22. New York Heart Association (NYHA) Classification

    Time frame: 3-years post implant

    Measure Description: Cardiac Disease with Functional Classes (lower value is more desirable than higher value) I - No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath.

    II - Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain.

    III - Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain.

    IV - Symptoms of heart failure at rest. Any physical activity causes further discomfort.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Surgery

Industry

Registry information

Official study 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)

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
May 4, 2017
Registry last updated
Aug 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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