Mitral StenosisMOMENTISNCT05526560
Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
An observational study of Mitral Stenosis and Mitral Valve Insufficiency, run by Edwards Lifesciences at 34 sites in 4 countries.
Trial summary
Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Stenosis, Mitral Valve Insufficiency
- What is being tested?
- MITRIS RESILIA Mitral Valve, Model 11400M
- Type of treatment
- Medical device
- How many people
- 504 participants
- Where
- 34 sitesin 4 countries
- Study dates
- 11 Jan 2023to Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring replacement of their native or prosthetic mitral valve
Who may be able to join
- 18 years or older at the time of informed consent
- Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
- Provides written informed consent
- Willingness to follow protocol requirements
Who cannot join
- Active endocarditis 3 months prior to the procedure
- Stage 4 renal disease or requiring dialysis
- Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
- High predicted risk of mortality prior to procedure
- Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) score of > 8 or
- Surgeon estimated risk of mortality of > 8
Trial locations and contacts
34 sites in 4 countries.
34 sites in 4 countries
United States20 sites
University of Michigan
Ann Arbor, Michigan, 48109
Piedmont Heart Institute
Athens, Georgia, 30606
Piedmont Heart Institute
Atlanta, Georgia, 30309
Ascension St. Vincent Heart Center
Carmel, Indiana, 46290
Duke University Medical Center
Durham, North Carolina, 27703
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Tristar Centennial Medical Center
Nashville, Tennessee, 37203
Ascension Saint Thomas
Nashville, Tennessee, 37205
Mount Sinai Hospital
New York, New York, 10029
Columbia University Irving Medical Center
New York, New York, 10032
Weill Cornell Medicine
New York, New York, 10065
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
AdventHealth Orlando
Orlando, Florida, 32803
Stanford University
Palo Alto, California, 94305
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
UPMC Presbyterian Shadyside
Pittsburgh, Pennsylvania, 15232
Mayo Clinic, Rochester
Rochester, Minnesota, 55905
University of Utah
Salt Lake City, Utah, 84112
Washington University Barnes-Jewish Hospital
St Louis, Missouri, 63110
Germany6 sites
Universitätsklinikum Augsburg
Augsburg, 86156
Rhoen-Klinikum Campus Bad Neustadt
Bad Neustadt an der Saale, 97616
Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545
University Clinic Bonn
Bonn, 53127
Klinikum Links der Weser
Bremen, 28277
Deutsches Herzzentrum München
München, 80636
Canada4 sites
London Health Sciences Centre, University Hospital (LHSC)
London, Ontario, N6G 5G1
Montreal Heart Institute
Montreal, Quebec, H1T 1C8
Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval
Québec, QC G1V 4G5
St. Paul's Hospital and Vancouver General Hospital
Vancouver, British Columbia, V6Z 1Y6
United Kingdom4 sites
Royal Papworth Hospital
Cambridge, SE5 9RS
St. Thomas Hospital
London, SE1 7EH
King's College Hospital
London, SE5 9RS
Cleveland Clinic London
London, SW1X 7HY
About this study
Official title: A Prospective, Global Study Designed to Collect Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.
Read the detailed description
MOMENTIS is a prospective, observational, single-arm, multicenter global study designed to collect real-world clinical outcomes in up to 500 subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.
- Conditions
- Mitral Stenosis, Mitral Valve Insufficiency
- Being tested
- MITRIS RESILIA Mitral Valve, Model 11400M
- Keywords
- Mitral Valve Replacement
- Medical subject headings
- Mitral Valve Stenosis, Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MITRIS RESILIA Mitral Valve, Model 11400MDevice
Replacement of mitral valve with MITRIS RESLIA Mitral Valve
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring replacement of their native or prosthetic mitral valve | Patients requiring replacement of their native or prosthetic mitral valve Receives: Device: MITRIS RESILIA Mitral Valve, Model 11400M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from valve related death or valve related reintervention
Freedom from valve related death or valve related reintervention at 1 year as determined by the Clinical Events Committee
Measured: 1 year
Hemodynamic performance as measured by peak and mean gradient by echocardiography
Hemodynamic performance at 1 year as confirmed by echocardiography and Echo Core Lab evaluation
Measured: 1 year
Secondary outcomes (4)
Early rates of major cardiac events
Early (<=30 days) rates of major cardiac events
Measured: 0 to 30 days
Late linearized rates of major cardiac events
Linearized rates of late (>30 days) major cardiac events
Measured: >30 days and up through 10 years post implant
Functional improvement from baseline for New York Heart Association (NYHA) Class
Functional improvement from baseline for NYHA Class
Measured: Annually up to 10 years post implant
Improvement from baseline for Quality of Life
Improvement from baseline for Quality of Life as measured by the Short Form (36) Health Survey (SF-36v2) (0-100 scale, with a higher score indicating less disability)
Measured: 1, 3, 5, 8, and 10 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 posted2 Sep 2022
- Study start11 Jan 2023
- Primary completionJan 2028 (estimated)
- Study completionDec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral StenosisStudies of the same condition, open and under way.
- More trials run by Edwards LifesciencesThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gorav Ailawadi, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526560
- Sponsor's protocol ID
- 2022-09
- Acronym
- MOMENTIS
- Status last verified
- May 2026
- First submitted
- 25 Aug 2022
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual participant data will not be available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Global Study Designed to Collect Real-world Clinical Outcomes of the MITRIS RESILIA Mitral Valve
- ClinicalTrials.gov ID
- NCT05526560
- Acronym / sponsor ID
- MOMENTIS / 2022-09
- Conditions
- Mitral Stenosis, Mitral Valve Insufficiency
- Keywords
- Mitral Valve Replacement
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Dec 2035 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Collect real-world data on acute and long-term safety and performance of the MITRIS RESILIA Mitral Valve, Model 11400M, in subjects requiring replacement of their native or prosthetic mitral valve with or without concomitant procedures.
Detailed description
MOMENTIS is a prospective, observational, single-arm, multicenter global study designed to collect real-world clinical outcomes in up to 500 subjects who have received the MITRIS RESILIA Mitral Valve, Model 11400M.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring replacement of their native or prosthetic mitral valve | – | Device: MITRIS RESILIA Mitral Valve, Model 11400MPatients requiring replacement of their native or prosthetic mitral valve |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring replacement of their native or prosthetic mitral valve
Key inclusion criteria (4 listed)
- 18 years or older at the time of informed consent
- Has a dysfunctional native or prosthetic mitral valve and requires mitral valve replacement surgery
- Provides written informed consent
- Willingness to follow protocol requirements
Key exclusion criteria (6 listed)
- Active endocarditis 3 months prior to the procedure
- Stage 4 renal disease or requiring dialysis
- Less than 2-year life expectancy due to non-cardiovascular life-threatening disease
- High predicted risk of mortality prior to procedure
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 |
|---|---|---|
| MITRIS RESILIA Mitral Valve, Model 11400MReplacement of mitral valve with MITRIS RESLIA Mitral Valve | Device | Patients requiring replacement of their native or prosthetic mitral valve |
Primary outcome
Freedom from valve related death or valve related reintervention
Time frame: 1 year
Freedom from valve related death or valve related reintervention at 1 year as determined by the Clinical Events Committee
Hemodynamic performance as measured by peak and mean gradient by echocardiography
Time frame: 1 year
Hemodynamic performance at 1 year as confirmed by echocardiography and Echo Core Lab evaluation
4 secondary outcomes
Early rates of major cardiac events
Time frame: 0 to 30 days
Late linearized rates of major cardiac events
Time frame: >30 days and up through 10 years post implant
Functional improvement from baseline for New York Heart Association (NYHA) Class
Time frame: Annually up to 10 years post implant
Improvement from baseline for Quality of Life
Time frame: 1, 3, 5, 8, and 10 years post implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be available to other researchers.
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Not yet recruitingObservational study
Evaluation of a Management Algorithm for TAVI Patients With Concomitant Mitral or Tricuspid Regurgitation
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Importance of Point-of-Care Ultrasound for Early Detection of Valvular and Cardiac Diseases (IMPROVE)
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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.
Gorav Ailawadi, MD principal investigator
University of Michigan
34 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Stenosis and Mitral Valve Insufficiency, run by Edwards Lifesciences at 34 sites in 4 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 6 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: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Germany, Canada, United Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
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?
Freedom from valve related death or valve related reintervention (time frame: 1 year). 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 22 May 2026.