TVMR With the INNOVALVE System Trial - Early Feasibility Study

Recruiting now · Not applicable

Conditions studied: Mitral Valve Regurgitation (Degenerative or Functional)

In brief

Study to evaluate the safety and performance of the INNOVALVE system

Key facts

Study ID

NCT04919980

Run by

Edwards Lifesciences

People needed

65

Starts

2022-09-01

Expected to finish

2031-07-01

Last updated by the study team

2026-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Swedish Medical Center — Seattle, Washington, United States (enrolling)
• Stanford University — Palo Alto, California, United States (enrolling)
• Naples Comprehensive Health — Naples, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• Piedmont Heart Institute — Atlanta, Georgia, United States (enrolling)
• Northwestern — Chicago, Illinois, United States (enrolling)
• University of Michigan Hospital and Health Systems — Ann Arbor, Michigan, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Saint Luke's Hospital — Kansas City, Missouri, United States (enrolling)
• Morristown Medical Center — Morristown, New Jersey, United States (enrolling)
• Northwell Health — Manhasset, New York, United States (enrolling)
• Cedars-Sinai — Los Angeles, California, United States (enrolling)
• NewYork-Presbyterian / Columbia University — New York, New York, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• OhioHealth Research Institute — Columbus, Ohio, United States (enrolling)
• Oregon Health & Science Universtiy — Portland, Oregon, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Vanderbilt University Medical Center — Nashville, Tennessee, United States (enrolling)
• Ascension Saint Thomas — Nashville, Tennessee, United States (enrolling)
• Cornell — New York, New York, United States

Full record on ClinicalTrials.gov

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