Back to Trials
NCT04919980NARecruiting

TVMR With the INNOVALVE System Trial - Early Feasibility Study

Edwards Lifesciences

Start Date

9/1/2022

Completion Date

7/1/2031

Summary

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

Eligibility Criteria

Age Range: 18 years to No maximum

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%

Interventions

DEVICE

INNOVALVE system

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Mitral Valve Regurgitation (Degenerative or Functional)

Locations

Cedars-Sinai

Los Angeles, California 90048

United States

Stanford University

Palo Alto, California 94305

United States

Naples Comprehensive Health

Naples, Florida 34102

United States

Emory University

Atlanta, Georgia 30308

United States

Piedmont Heart Institute

Atlanta, Georgia 30309

United States

Northwestern

Chicago, Illinois 60611

United States

University of Michigan Hospital and Health Systems

Ann Arbor, Michigan 48109

United States

Mayo Clinic

Rochester, Minnesota 555905

United States

Saint Luke's Hospital

Kansas City, Missouri 64111

United States

Morristown Medical Center

Morristown, New Jersey 07960

United States

Northwell Health

Manhasset, New York 11030

United States

Cornell

New York, New York 10021

United States

NewYork-Presbyterian / Columbia University

New York, New York 10032

United States

Cleveland Clinic

Cleveland, Ohio 44195

United States

OhioHealth Research Institute

Columbus, Ohio 43214

United States

Oregon Health & Science Universtiy

Portland, Oregon 97239

United States

University of Pennsylvania

Philadelphia, Pennsylvania 19104

United States

Vanderbilt University Medical Center

Nashville, Tennessee 37203

United States

Ascension Saint Thomas

Nashville, Tennessee 37205

United States

Swedish Medical Center

Seattle, Washington 98122

United States