Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04919980

TVMR With the INNOVALVE System Trial - Early Feasibility Study

Led by Edwards Lifesciences · Updated on 2026-01-30

65

Participants Needed

17

Research Sites

460 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Study to evaluate the safety and performance of the INNOVALVE system

CONDITIONS

Official Title

TVMR With the INNOVALVE System Trial - Early Feasibility Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinically significant, symptomatic mitral regurgitation
  • High risk for open-heart surgery
  • Meets anatomical criteria
Not Eligible

You will not qualify if you...

  • Unsuitable anatomy
  • Patient is inoperable
  • Ejection fraction less than 25%

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Cedars-Sinai

Los Angeles, California, United States, 90048

Actively Recruiting

2

Naples Comprehensive Health

Naples, Florida, United States, 34102

Actively Recruiting

3

Piedmont Heart Institute

Atlanta, Georgia, United States, 30309

Actively Recruiting

4

Northwestern

Chicago, Illinois, United States, 60611

Actively Recruiting

5

University of Michigan Hospital and Health Systems

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

6

Mayo Clinic

Rochester, Minnesota, United States, 555905

Actively Recruiting

7

Morristown Medical Center

Morristown, New Jersey, United States, 07960

Actively Recruiting

8

Northwell Health

Manhasset, New York, United States, 11030

Actively Recruiting

9

Cornell

New York, New York, United States, 10021

Withdrawn

10

NewYork-Presbyterian / Columbia University

New York, New York, United States, 10032

Actively Recruiting

11

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

12

OhioHealth Research Institute

Columbus, Ohio, United States, 43214

Actively Recruiting

13

Oregon Health & Science Universtiy

Portland, Oregon, United States, 97239

Actively Recruiting

14

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

15

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37203

Actively Recruiting

16

Ascension Saint Thomas

Nashville, Tennessee, United States, 37205

Actively Recruiting

17

Swedish Medical Center

Seattle, Washington, United States, 98122

Actively Recruiting

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Research Team

T

TMTT Clinical

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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TVMR With the INNOVALVE System Trial - Early Feasibility Study | DecenTrialz