Heart Valve DiseasesNCT03139721
Medtronic HAMMOCK Post Approval Study
An observational study of Heart Valve Diseases, run by Medtronic Cardiac Surgery at 7 sites in 3 countries.
Trial summary
This study is being conducted to satisfy the post-CE approval requirement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Valve Diseases
- What is being tested?
- Mosaic model 305, model 310, and ultra model 305
- Type of treatment
- Medical device
- How many people
- 122 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 19 Jun 2017to 21 Jun 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Subjects requiring aortic or mitral valve replacement of the native valve.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
United States4 sites
Bellin Memorial Hospital
Green Bay, Wisconsin, 54301
Franciscan Saint Francis Health
Indianapolis, Indiana, 46237
Saint Joseph Medical Center
Tacoma, Washington, 98405
ProMedica Toledo Hospital
Toledo, Ohio, 43606
Germany2 sites
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Deutsches Herzzentrum München Klinik an der TU München
München, 80636
About this study
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)
This study is being conducted to satisfy the post-CE approval requirement.
- Conditions
- Heart Valve Diseases
- Being tested
- Mosaic model 305, model 310, and ultra model 305
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mosaic model 305, model 310, and ultra model 305Device
Also called Hancock II model T505, model T510, and ultra model T505
Aortic or mitral valve replacement
| Study group | Role | What they receive |
|---|---|---|
| Primary cohort | Subjects requiring aortic or mitral valve replacement Receives: Device: Mosaic model 305, model 310, and ultra model 305 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Deaths, Reinterventions, or Explants
Number of deaths, reinterventions, or explants related to the valve
Measured: 1-year post implant
Number of Deaths, Reinterventions, or Explants
Number of deaths, reinterventions, or explants related to the valve
Measured: 3-years post implant
Secondary outcomes (22)
Mean Gradient (mmHg)
Measured by echocardiogram via Echo Core Lab
Measured: 1-year post implant
Peak Gradient (mmHg)
Measured by echocardiogram via Echo Core Lab
Measured: 1-year post implant
Effective Orifice Area (EOA)
Measured by echocardiogram via Echo Core Lab
Measured: 1-year post implant
Effective Orifice Area Index (EOAi)
EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area
Measured: 1-year post implant
Cardiac Output
Measured by echocardiogram via Echo Core Lab
Measured: 1-year post implant
Cardiac Index
Cardiac Output Measured by echocardiogram via Echo Core Lab/Body Surface Area
Measured: 1-year post implant
Performance Index
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.
Measured: 1-year post implant
Transvalvular Regurgitation
Measured by echocardiogram via Echo Core Lab
Measured: 1-year post implant
Paravalvular Regurgitation
Measured by echocardiogram via Echo Core Lab
Measured: 1-year post implant
Total Regurgitation
Measured by echocardiogram via Echo Core Lab
Measured: 1-year post implant
New York Heart Association (NYHA) Classification
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.
Measured: 1-year post implant
Mean Gradient
Measured by echocardiogram via Echo Core Lab
Measured: 3-years post implant
Peak Gradient
Measured by echocardiogram via Echo Core Lab
Measured: 3-years post implant
Effective Orifice Area (EOA)
Measured by echocardiogram via Echo Core Lab
Measured: 3-years post implant
Effective Orifice Area Index (EOAi)
EOA Measured by echocardiogram via Echo Core Lab/Body Surface Area
Measured: 3-years post implant
Cardiac Output
Measure by echocardiogram via Echo Core Lab
Measured: 3-years post implant
Cardiac Index
Cardiac output measured by echocardiogram via Echo Core Lab/Body Surface Area
Measured: 3-years post implant
Performance Index
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.
Measured: 3-years post implant
Transvalvular Regurgitation
Measured by echocardiogram via Echo Core Lab
Measured: 3-years post implant
Paravalvular Regurgitation
Measured by echocardiogram via Echo Core Lab
Measured: 3-years post implant
Total Regurgitation
Measured by echocardiogram via Echo Core Lab
Measured: 3-years post implant
New York Heart Association (NYHA) Classification
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.
Measured: 3-years post implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start19 Jun 2017
- Primary completion17 May 2019
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart Valve DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Surgery
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03139721
- Sponsor's protocol ID
- 1024882DOC
- Status last verified
- Aug 2024
- First submitted
- 17 Apr 2017
- Last updated
- 23 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03139721
- Acronym / sponsor ID
- 1024882DOC
- Conditions
- Heart Valve Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Medtronic Cardiac SurgeryIndustry (pharma, biotech, devices)
- Study start
- 19 Jun 2017 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Posted 23 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to satisfy the post-CE approval requirement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary cohort | – | Device: Mosaic model 305, model 310, and ultra model 305Subjects requiring aortic or mitral valve replacement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects requiring aortic or mitral valve replacement of the native valve.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mosaic model 305, model 310, and ultra model 305Also: Hancock II model T505, model T510, and ultra model T505Aortic or mitral valve replacement | Device | Primary cohort |
Primary outcome
Number of Deaths, Reinterventions, or Explants
Time frame: 1-year post implant
Number of deaths, reinterventions, or explants related to the valve
Number of Deaths, Reinterventions, or Explants
Time frame: 3-years post implant
Number of deaths, reinterventions, or explants related to the valve
22 secondary outcomes
Mean Gradient (mmHg)
Time frame: 1-year post implant
Peak Gradient (mmHg)
Time frame: 1-year post implant
Effective Orifice Area (EOA)
Time frame: 1-year post implant
Effective Orifice Area Index (EOAi)
Time frame: 1-year post implant
Cardiac Output
Time frame: 1-year post implant
Cardiac Index
Time frame: 1-year post implant
Performance Index
Time frame: 1-year post implant
Transvalvular Regurgitation
Time frame: 1-year post implant
Paravalvular Regurgitation
Time frame: 1-year post implant
Total Regurgitation
Time frame: 1-year post implant
New York Heart Association (NYHA) Classification
Time frame: 1-year post implant
Mean Gradient
Time frame: 3-years post implant
Peak Gradient
Time frame: 3-years post implant
Effective Orifice Area (EOA)
Time frame: 3-years post implant
Effective Orifice Area Index (EOAi)
Time frame: 3-years post implant
Cardiac Output
Time frame: 3-years post implant
Cardiac Index
Time frame: 3-years post implant
Performance Index
Time frame: 3-years post implant
Transvalvular Regurgitation
Time frame: 3-years post implant
Paravalvular Regurgitation
Time frame: 3-years post implant
Total Regurgitation
Time frame: 3-years post implant
New York Heart Association (NYHA) Classification
Time frame: 3-years post implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Valve Diseases, run by Medtronic Cardiac Surgery at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Germany, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Deaths, Reinterventions, or Explants (time frame: 1-year post implant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.