TVMR With the INNOVALVE System Trial - Early Feasibility Study (TWIST-EFS)

May 26, 2026 updated by: Edwards Lifesciences
Study to evaluate the safety and performance of the INNOVALVE system

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai
        • Principal Investigator:
          • Rajendra Makkar, MD
        • Contact:
      • Palo Alto, California, United States, 94305
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Alan Yeung, MD
    • Florida
      • Naples, Florida, United States, 34102
        • Recruiting
        • Naples Comprehensive Health
        • Principal Investigator:
          • Robert Cubeddu, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Recruiting
        • Piedmont Heart Institute
        • Principal Investigator:
          • Vinod Thourani, MD
        • Contact:
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University
        • Principal Investigator:
          • Adam Greenbaum, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern
        • Principal Investigator:
          • Charles Davidson, MD
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Hospital and Health Systems
        • Principal Investigator:
          • Stanley Chetcuti, MD
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 555905
        • Recruiting
        • Mayo Clinic
        • Contact:
        • Principal Investigator:
          • Mackram Eleid, MD
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • Saint Luke's Hospital
        • Principal Investigator:
          • Adnan Chhatriwalla, MD
        • Contact:
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Recruiting
        • Morristown Medical Center
        • Contact:
        • Principal Investigator:
          • Gennaro Giustino, MD
    • New York
      • Manhasset, New York, United States, 11030
        • Recruiting
        • Northwell Health
        • Principal Investigator:
          • Bruce Rutkin, MD
        • Contact:
      • New York, New York, United States, 10032
        • Recruiting
        • NewYork-Presbyterian / Columbia University
        • Contact:
        • Principal Investigator:
          • Susheel Kodali, MD
      • New York, New York, United States, 10021
        • Withdrawn
        • Cornell
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Samir Kapadia, MD
      • Columbus, Ohio, United States, 43214
        • Recruiting
        • OhioHealth Research Institute
        • Contact:
        • Principal Investigator:
          • Carlos Sanchez, MD
        • Sub-Investigator:
          • Steven Yakubov, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science Universtiy
        • Principal Investigator:
          • Firas Zahr, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • University of Pennsylvania
        • Contact:
        • Principal Investigator:
          • Paul Fiorilli, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Colin M Barker, MD
      • Nashville, Tennessee, United States, 37205
        • Recruiting
        • Ascension Saint Thomas
        • Principal Investigator:
          • Andrew Morse, MD
        • Contact:
    • Washington
      • Seattle, Washington, United States, 98122
        • Recruiting
        • Swedish Medical Center
        • Principal Investigator:
          • Sidakpal Panaich, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinically significant, symptomatic mitral regurgitation
  • High risk for open-heart surgery
  • Meets anatomical criteria

Exclusion Criteria:

  • Unsuitable anatomy
  • Patient is inoperable
  • EF<25%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
MV replacement with INNOVALVE system
Device: INNOVALVE system
INNOVALVE system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of implant or delivery related serious adverse events at 30 Days
Time Frame: 30 days
Absence of implant or delivery related serious adverse events
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Procedural success
Time Frame: 30 days
30 days
Technical success
Time Frame: Procedure
Procedure
NYHA functional class
Time Frame: 30 days, 6, 12 months and annually up to 5 years
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
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
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
30 days, 6, 12 months and annually up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Edwards Lifesciences

Investigators

  • Principal Investigator: Chet Rihal, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2022

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2031

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 3, 2021

First Posted (Actual)

June 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-13

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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