Mitral RegurgitationNCT04820764
EFS of the CardioMech MVRS
A study testing CardioMech MVRS in people with Mitral Regurgitation, run by CardioMech AS at 12 sites in United States.
Trial summary
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Regurgitation
- What is being tested?
- CardioMech MVRS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 12 sitesUnited States
- Study dates
- 27 Jul 2021to Sep 2031
- Phase
- Interventional
- 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
Who may be able to join
- Eighteen (18) years of age or greater
- Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail
- Intermediate or high surgical risk for mitral valve repair
Who cannot join
- History of rheumatic heart disease
- History of prior endocarditis
- History of prior repair or replacement of the mitral valve, or annuloplasty
- Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment
- Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Atrium Health Sanger Heart and Vascular Institute
Charlotte, North Carolina, 28204
The Christ Hospital
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Northwestern University
Evanston, Illinois, 60208
Intermountain Medical Center
Murray, Utah, 84107
Ascension St. Thomas West
Nashville, Tennessee, 37205
NYU Langone
New York, New York, 10016
Baylor Scott & White, The Heart Hospital
Plano, Texas, 75093
Mayo Clinic
Rochester, Minnesota, 55902
CentraCare Heart & Vascular Center
Saint Cloud, Minnesota, 56303
Cardiovascular Institute of Los Robles Health System
Thousand Oaks, California, 91360
Ascension St. Francis via Christi
Wichita, Kansas, 67226
About this study
Official title: Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Read the detailed description
The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥3+) or severe (≥4+), symptomatic, degenerative mitral regurgitation and who are determined to be at intermediate or high surgical risk for mitral valve repair, as assessed by the site's multidisciplinary heart team.
- Conditions
- Mitral Regurgitation
- Being tested
- CardioMech MVRS
- Medical subject headings
- Mitral Valve Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioMech MVRSDevice
CardioMech MVRS
| Study group | Role | What they receive |
|---|---|---|
| CardioMech Mitral Valve Repair System (MVRS) | Experimental | Not described Receives: Device: CardioMech MVRS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
Measured: 30 days
Change in MR grade
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start27 Jul 2021
- Primary completionSep 2026 (estimated)
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral RegurgitationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CardioMech AS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mathew Williams, MD, Principal investigator, NYU LangoneMayra Guerrero, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04820764
- Sponsor's protocol ID
- 10228
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study of the CardioMech Mitral Valve Repair System (MVRS)
- ClinicalTrials.gov ID
- NCT04820764
- Acronym / sponsor ID
- 10228
- Conditions
- Mitral Regurgitation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- CardioMech ASIndustry (pharma, biotech, devices)
- Study start
- 27 Jul 2021 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2031 (estimated)
- First posted
- 29 Mar 2021 (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.
Safety and performance evaluation of the CardioMech Mitral Valve Repair System (MVRS) in patients with degenerative mitral valve regurgitation.
Detailed description
The purpose of the clinical study is to obtain clinical data on the CardioMech Mitral Valve Repair System (MVRS) in patients diagnosed with moderate to severe (≥3+) or severe (≥4+), symptomatic, degenerative mitral regurgitation and who are determined to be at intermediate or high surgical risk for mitral valve repair, as assessed by the site's multidisciplinary heart team.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CardioMech Mitral Valve Repair System (MVRS) | Experimental | Device: CardioMech MVRS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Eighteen (18) years of age or greater
- Moderate to severe (≥3+) or severe (≥4+) mitral valve regurgitation (per American Society of Echocardiography (ASE) guidelines) due to mitral valve prolapse or flail
- Intermediate or high surgical risk for mitral valve repair
Key exclusion criteria (5 listed)
- History of rheumatic heart disease
- History of prior endocarditis
- History of prior repair or replacement of the mitral valve, or annuloplasty
- Severely calcified mitral leaflet or has evidence of calcification in the grasping area of the leaflets that would prevent leaflet anchor positioning and deployment
- Complex mechanism of MR (leaflet perforation, severe leaflet calcifications, commissural extension, commissural prolapse, multiple flail or prolapsing segments, cleft) present on required imaging
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 |
|---|---|---|
| CardioMech MVRSCardioMech MVRS | Device | CardioMech Mitral Valve Repair System (MVRS) |
Primary outcome
Freedom from serious adverse events determined to be related to the CardioMech MVRS device or procedure
Time frame: 30 days
Change in MR grade
Time frame: 30 days
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 25 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Mitral Regurgitation
Recruiting
PRECISE-AFMR I: Transcatheter Mitral Valve Edge-to-Edge Repair for Atrial Functional Mitral Regurgitation in Patients at High Surgical Risk
Atrial Functional, Mitral Regurgitation (MR)
Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation
Mitral Regurgitation Functional, Mitral Valve Disease
Not yet recruiting
The PALMETTO Study
Mitral Regurgitation
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Recruiting
Edge-to-edge Mitral Valve Repair in ATTR-CM
Mitral Regurgitation, ATTR-Cardiomyopathy
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.
Mathew Williams, MD principal investigator
NYU Langone
Mayra Guerrero, MD principal investigator
Mayo Clinic
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CardioMech MVRS in people with Mitral Regurgitation, run by CardioMech AS at 12 sites in United States.
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 3 inclusion and 5 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 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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 serious adverse events determined to be related to the CardioMech MVRS device or procedure (time frame: 30 days). 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 25 Sep 2026.