Medtronic HAMMOCK Post Approval Study

August 20, 2024 updated by: Medtronic Cardiac Surgery

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)

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Universitätsklinikum Hamburg-Eppendorf
      • München, Germany, 80636
        • Deutsches Herzzentrum München Klinik an der TU München
  • Poland
      • Warsaw, Poland
        • Institute of Cardiology in Warsaw
  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • Franciscan Saint Francis Health
    • Ohio
      • Toledo, Ohio, United States, 43606
        • ProMedica Toledo Hospital
    • Washington
      • Tacoma, Washington, United States, 98405
        • Saint Joseph Medical Center
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • Bellin Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Primary cohort
Subjects requiring aortic or mitral valve replacement
Device: Mosaic model 305, model 310, and ultra model 305
Aortic or mitral valve replacement
Other Names:
  • Hancock II model T505, model T510, and ultra model T505

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Deaths, Reinterventions, or Explants
Time Frame: 1-year post implant
Number of deaths, reinterventions, or explants related to the valve
1-year post implant
Number of Deaths, Reinterventions, or Explants
Time Frame: 3-years post implant
Number of deaths, reinterventions, or explants related to the valve
3-years post implant

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean Gradient (mmHg)
Time Frame: 1-year post implant
Measured by echocardiogram via Echo Core Lab
1-year post implant
Peak Gradient (mmHg)
Time Frame: 1-year post implant
Measured by echocardiogram via Echo Core Lab
1-year post implant
Effective Orifice Area (EOA)
Time Frame: 1-year post implant
Measured by echocardiogram via Echo Core Lab
1-year post implant
Effective Orifice Area Index (EOAi)
Time Frame: 1-year post implant
EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area
1-year post implant
Cardiac Output
Time Frame: 1-year post implant
Measured by echocardiogram via Echo Core Lab
1-year post implant
Cardiac Index
Time Frame: 1-year post implant
Cardiac Output Measured by echocardiogram via Echo Core Lab/Body Surface Area
1-year post implant
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.
1-year post implant
Transvalvular Regurgitation
Time Frame: 1-year post implant
Measured by echocardiogram via Echo Core Lab
1-year post implant
Paravalvular Regurgitation
Time Frame: 1-year post implant
Measured by echocardiogram via Echo Core Lab
1-year post implant
Total Regurgitation
Time Frame: 1-year post implant
Measured by echocardiogram via Echo Core Lab
1-year post implant
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.
1-year post implant
Mean Gradient
Time Frame: 3-years post implant
Measured by echocardiogram via Echo Core Lab
3-years post implant
Peak Gradient
Time Frame: 3-years post implant
Measured by echocardiogram via Echo Core Lab
3-years post implant
Effective Orifice Area (EOA)
Time Frame: 3-years post implant
Measured by echocardiogram via Echo Core Lab
3-years post implant
Effective Orifice Area Index (EOAi)
Time Frame: 3-years post implant
EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area
3-years post implant
Cardiac Output
Time Frame: 3-years post implant
Measure by echocardiogram via Echo Core Lab
3-years post implant
Cardiac Index
Time Frame: 3-years post implant
Cardiac output measured by echocardiogram via Echo Core Lab/Body Surface Area
3-years post implant
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.
3-years post implant
Transvalvular Regurgitation
Time Frame: 3-years post implant
Measured by echocardiogram via Echo Core Lab
3-years post implant
Paravalvular Regurgitation
Time Frame: 3-years post implant
Measured by echocardiogram via Echo Core Lab
3-years post implant
Total Regurgitation
Time Frame: 3-years post implant
Measured by echocardiogram via Echo Core Lab
3-years post implant
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.
3-years post implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medtronic Cardiac Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 19, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 1, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 4, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 23, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1024882DOC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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