AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

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
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

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.

TMTT Clinical contact

(949) 250-2500

TMTT_Clinical@edwards.com

21 sites in 1 country

United States21 sites, 19 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

    Recruiting

  • Cornell

    New York, New York, 10021

    Withdrawn

  • NewYork-Presbyterian / Columbia University

    New York, New York, 10032

    Active, not 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

    Recruiting

Other trials in United States

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 groups in NCT04919980
Study groupRoleWhat they receive
TreatmentExperimentalMV 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.

  1. Serious adverse events (SAE) through 30 days post-procedure

    Serious adverse events (SAE) through 30 days post-procedure

    Measured: 30 days

Secondary outcomes (6)

  1. Technical success

    Measured: Procedure

  2. Procedural success

    Measured: 30 days

  3. NYHA functional class

    Measured: 30 days, 6, 12 months and annually up to 5 years

  4. Six-minute walk test

    Measured: 30 days, 6, 12 months and annually up to 5 years

  5. Quality of life improvement (KCCQ-12)

    Measured: 30 days, 6, 12 months and annually up to 5 years

  6. 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.

  1. First posted9 Jun 2021
  2. Study start1 Sep 2022
  3. Primary completion1 Jul 2028 (estimated)
  4. Study completion1 Jul 2034 (estimated)

Resources

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)
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

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in