Mitral Valve Regurgitation (Degenerative or Functional)NCT02718001
Edwards EVOQUE Eos MISCEND Study
A study testing Edwards EVOQUE Eos Mitral Valve Replacement System in people with Mitral Valve Regurgitation (Degenerative or Functional), run by Edwards Lifesciences at 19 sites in 2 countries.
Trial summary
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Regurgitation (Degenerative or Functional)
- What is being tested?
- Edwards EVOQUE Eos Mitral Valve Replacement System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 6 Feb 2015to 30 Apr 2033
- 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
- Clinically significant, symptomatic mitral regurgitation
- High risk for open-heart surgery
- Meets anatomical criteria
Who cannot join
- Unsuitable anatomy
- Patient is inoperable
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States16 sites
Emory University Hospital/Emory University Hospital Midtown
Atlanta, Georgia, 30322
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Sutter Mills-Peninsula
Burlingame, California, 94010
University of Virginia Health System
Charlottesville, Virginia, 22908
Northwestern University
Chicago, Illinois, 60611
Cleveland Clinic
Cleveland, Ohio, 44195
The University of Texas Health Science Center at Houston/Memorial Hermann Texas Medical Center
Houston, Texas, 77030
St. Vincent Heart Center
Indianapolis, Indiana, 46260
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Morristown Medical Center
Morristown, New Jersey, 07960
Intermountain Medical Center
Murray, Utah, 84107
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
The Heart Hospital Baylor Plano
Plano, Texas, 75093
Oregon Health & Science University
Portland, Oregon, 97239
St. Francis Hospital
Roslyn, New York, 11576
Kaiser Permanente San Francisco
San Francisco, California, 94118
Canada3 sites
Institut Universitaire de Cardiologie et de Pneumologie de Quebec-Université Laval
Québec, G1V 4G5
St. Michael's Hospital
Toronto
St. Paul's Hospital
Vancouver, British Columbia
About this study
Official title: Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND)
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
Read the detailed description
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system.
- Being tested
- Edwards EVOQUE Eos Mitral Valve Replacement System
- Keywords
- Mitral, Regurgitation, Insufficiency, Degenerative, Functional, Primary, Secondary, Organic, Transcatheter, TMVR, TMVI, Heart Valve, Mitral Valve, Transseptal, Trans-Septal, Transeptal, Severe
- Medical subject headings
- Mitral Valve Insufficiency, Gastroesophageal Reflux, Neoplasm Metastasis, Lymphoma, Follicular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edwards EVOQUE Eos Mitral Valve Replacement SystemDevice
Also called CardiAQ-Edwards™ Transcatheter Mitral Valve (TMV), Edwards FORTIS™ Transcatheter Mitral Valve (TMV), Transcatheter Mitral Valve Replacement (TMVR), Edwards EVOQUE Transcatheter Mitral Valve Replacement System
Replacement of the mitral valve through a transcatheter approach
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with the Edwards EVOQUE Eos mitral valve replacement system Receives: Device: Edwards EVOQUE Eos Mitral Valve Replacement System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major adverse events
Proportion of patients with major adverse events
Measured: 30 days
Secondary outcomes (6)
NYHA functional class
Number of patients with improvement in NYHA class
Measured: 30 days, 6 Months, 12 Months, annual for five years
Six minute walk test
Increase in distance (m) from baseline
Measured: 30 days, 6 Months, 12 Months, annual for five years
Reduction in MR grade
Number of patients with reduction in MR grade from baseline
Measured: 30 days, 6 Months, 12 Months, annual for five years
Device Success
Proportion of patients with device deployed as intended and delivery system successfully retrieved
Measured: Immediately after procedure
Procedural Success
Proportion of patients with device success without significant paravalvular leak
Measured: Discharge or 7 days post-procedure, whichever occurs first
Clinical Success
Proportion of patients with procedural success without major adverse events
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 posted24 Mar 2016 (estimated)
- Study start6 Feb 2015
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve Regurgitation (Degenerative or Functional)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajendra Makkar, MD, Principal investigator, Cedars-Sinai Medical Center, Los Angeles, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02718001
- Sponsor's protocol ID
- 2013-05C
- Status last verified
- Apr 2026
- First submitted
- 1 Mar 2016
- Last updated
- 13 Apr 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 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Edwards EVOQUE Eos Mitral Valve Replacement: Investigation of Safety and Performance After Mitral Valve Replacement With Transcatheter Device (MISCEND)
- ClinicalTrials.gov ID
- NCT02718001
- Acronym / sponsor ID
- 2013-05C
- Keywords
- Mitral, Regurgitation, Insufficiency, Degenerative, Functional, Primary, Secondary, Organic
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2015 (actual)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2033 (estimated)
- First posted
- 24 Mar 2016 (estimated)
- 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.
Study to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system
Detailed description
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards EVOQUE Eos mitral valve replacement system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Edwards EVOQUE Eos Mitral Valve Replacement SystemTreatment with the Edwards EVOQUE Eos mitral valve replacement system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically significant, symptomatic mitral regurgitation
- High risk for open-heart surgery
- Meets anatomical criteria
Key exclusion criteria (2 listed)
- Unsuitable anatomy
- Patient is inoperable
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 |
|---|---|---|
| Edwards EVOQUE Eos Mitral Valve Replacement SystemAlso: CardiAQ-Edwards™ Transcatheter Mitral Valve (TMV), Edwards FORTIS™ Transcatheter Mitral Valve (TMV), Transcatheter Mitral Valve Replacement (TMVR), Edwards EVOQUE Transcatheter Mitral Valve Replacement SystemReplacement of the mitral valve through a transcatheter approach | Device | Treatment |
Primary outcome
Composite of major adverse events
Time frame: 30 days
Proportion of patients with major adverse events
6 secondary outcomes
NYHA functional class
Time frame: 30 days, 6 Months, 12 Months, annual for five years
Six minute walk test
Time frame: 30 days, 6 Months, 12 Months, annual for five years
Reduction in MR grade
Time frame: 30 days, 6 Months, 12 Months, annual for five years
Device Success
Time frame: Immediately after procedure
Procedural Success
Time frame: Discharge or 7 days post-procedure, whichever occurs first
Clinical Success
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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Recruiting
Mitral Annular Repair With the CathHELIX™ Transcatheter System in Subjects With FMR
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Active, not recruiting
TVMR With the Innovalve System Trial - Pilot Study in Italy
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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.
Rajendra Makkar, MD principal investigator
Cedars-Sinai Medical Center, Los Angeles, CA
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edwards EVOQUE Eos Mitral Valve Replacement System in people with Mitral Valve Regurgitation (Degenerative or Functional), run by Edwards Lifesciences at 19 sites in 2 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 3 inclusion and 2 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. 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?
Composite of major adverse events (time frame: 30 days). 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 13 Apr 2026.