Mitral Valve Regurgitation (Degenerative or Functional)TWIST-EFSNCT04919980
TVMR With the INNOVALVE System Trial - Early Feasibility Study
A study testing INNOVALVE system in people with Mitral Valve Regurgitation (Degenerative or Functional), run by Edwards Lifesciences at 21 sites in United States.
Trial summary
Study to evaluate the safety and performance of the INNOVALVE 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?
- INNOVALVE system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 21 sitesUnited States
- Study dates
- 1 Sep 2022to 1 Jul 2034
- 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
- EF<25%
Trial locations and contacts
21 sites in 1 country. Contact the study team or a site near you to ask about taking part.
21 sites in 1 country
United States21 sites, 19 recruiting
- Recruiting
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, 48109
Keoni Fordham, 734-763-6551, fordham@med.umich.edu
Stanley Chetcuti, MD
- Recruiting
Emory University
Atlanta, Georgia, 30308
Elizabeth Charles, 404-686-1249, echarl2@emory.edu
Adam Greenbaum, MD
- Recruiting
Piedmont Heart Institute
Atlanta, Georgia, 30309
Jennifer Bolivar Aldana, 770-846-0344, jennifer.bolivaraldana@piedmont.org
Vinod Thourani, MD
- Recruiting
Northwestern
Chicago, Illinois, 60611
BCVI Clinical Trials Unit, 312-926-4000, heartresearch@northwestern.edu
Charles Davidson, MD
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Emily Tylicki, 216-444-6950, tylicke@ccf.org
Samir Kapadia, MD
- Recruiting
OhioHealth Research Institute
Columbus, Ohio, 43214
Katy Monnin, 614-566-5768, katy.monnin@ohiohealth.com
Carlos Sanchez, MD
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
Sahar Razmjou, 313-916-4475, srazmjo1@hfhs.org
Brian O'Neill, MD
- Recruiting
Saint Luke's Hospital
Kansas City, Missouri, 64111
Brianna Vann, 816-932-9614, bvann@saint-lukes.org
Adnan Chhatriwalla, MD
- Recruiting
Cedars-Sinai
Los Angeles, California, 90048
Mitch Gheorghiu, 310-407-9553, Mitch.Gheorghiu@cshs.org
Rajendra Makkar, MD
- Recruiting
Northwell Health
Manhasset, New York, 11030
Samantha Annunziato, 516-600-1475, sannunziato@northwell.edu
Bruce Rutkin, MD
- Recruiting
Morristown Medical Center
Morristown, New Jersey, 07960
Catherine Van Zile, 973-971-5951, catherine.vanzile@atlantichealth.org
Gennaro Giustino, MD
- Recruiting
Naples Comprehensive Health
Naples, Florida, 34102
Kathy Byrd, 239-624-8113, kathy.byrd@nchmd.org
Robert Cubeddu, MD
- Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Kathy Adams, 615-322-9845, kathy.adams@vumc.org
Natalie Jackson, 615-343-1782, natalie.jackson@vumc.org
- Recruiting
Ascension Saint Thomas
Nashville, Tennessee, 37205
Emily Normandin, 615-222-3852, emily.normandin@ascension.org
Andrew Morse, MD
- Withdrawn
Cornell
New York, New York, 10021
- Active, not recruiting
NewYork-Presbyterian / Columbia University
New York, New York, 10032
- Recruiting
Stanford University
Palo Alto, California, 94305
Anushka Marathe, 650-497-0903, amarathe@stanford.edu
Alan Yeung, MD
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Kelli Cook, 215-459-4478, kelli.cook@pennmedicine.upenn.edu
Paul Fiorilli, MD
- Recruiting
Oregon Health & Science Universtiy
Portland, Oregon, 97239
Emmanuel Mills, MD, 503-494-3925, millsem@ohsu.edu
Firas Zahr, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 555905
Carl Griffin, griffinii.carl@mayo.edu
Mackram Eleid, MD
- Recruiting
Swedish Medical Center
Seattle, Washington, 98122
Zaw Nu Dan, 206-215-2431, zawnu.dan@swedish.org
Sidakpal Panaich, MD
About this study
Study to evaluate the safety and performance of the INNOVALVE system
Read the detailed description
The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the INNOVALVE system
- Being tested
- INNOVALVE system
- 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.
INNOVALVE systemDevice
INNOVALVE system
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | MV replacement with INNOVALVE system Receives: Device: INNOVALVE system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious adverse events (SAE) through 30 days post-procedure
Serious adverse events (SAE) through 30 days post-procedure
Measured: 30 days
Secondary outcomes (6)
Technical success
Measured: Procedure
Procedural success
Measured: 30 days
NYHA functional class
Measured: 30 days, 6, 12 months and annually up to 5 years
Six-minute walk test
Measured: 30 days, 6, 12 months and annually up to 5 years
Quality of life improvement (KCCQ-12)
Measured: 30 days, 6, 12 months and annually up to 5 years
Reduction in MR grade
Measured: 30 days, 6, 12 months and annually up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start1 Sep 2022
- Primary completion1 Jul 2028 (estimated)
- Study completion1 Jul 2034 (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
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Edwards Lifesciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chet Rihal, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04919980
- Sponsor's protocol ID
- 2024-13
- Acronym
- TWIST-EFS
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2021
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TVMR With the INNOVALVE System Trial - Early Feasibility Study
- ClinicalTrials.gov ID
- NCT04919980
- Acronym / sponsor ID
- TWIST-EFS / 2024-13
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Edwards LifesciencesIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jul 2028 (estimated)
- Study completion
- 1 Jul 2034 (estimated)
- First posted
- 9 Jun 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.
Study to evaluate the safety and performance of the INNOVALVE system
Detailed description
The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the INNOVALVE 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: INNOVALVE systemMV replacement with INNOVALVE 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 (3 listed)
- Unsuitable anatomy
- Patient is inoperable
- EF<25%
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 |
|---|---|---|
| INNOVALVE systemINNOVALVE system | Device | Treatment |
Primary outcome
Serious adverse events (SAE) through 30 days post-procedure
Time frame: 30 days
Serious adverse events (SAE) through 30 days post-procedure
6 secondary outcomes
Technical success
Time frame: Procedure
Procedural success
Time frame: 30 days
NYHA functional class
Time frame: 30 days, 6, 12 months and annually up to 5 years
Six-minute walk test
Time frame: 30 days, 6, 12 months and annually up to 5 years
Quality of life improvement (KCCQ-12)
Time frame: 30 days, 6, 12 months and annually up to 5 years
Reduction in MR grade
Time frame: 30 days, 6, 12 months and annually up to 5 years
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 21 Sep 2026.
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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.
Chet Rihal principal investigator
Mayo Clinic
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing INNOVALVE system in people with Mitral Valve Regurgitation (Degenerative or Functional), run by Edwards Lifesciences at 21 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 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: looking for participants now, as of the sponsor's last update on 21 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 21 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?
Contact TMTT Clinical ((949) 250-2500, TMTT_Clinical@edwards.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious adverse events (SAE) through 30 days post-procedure (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 21 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.