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TVMR With the INNOVALVE System Trial - Early Feasibility Study

Recruiting

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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%

About the study

Study to evaluate the safety and performance of the INNOVALVE system

What is being tested

Sponsor: Edwards Lifesciences · Participants: 85 · Started: Sep 1, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT04919980

Locations in the U.S.

CaliforniaCedars-Sinai, Los Angeles
Stanford University, Palo Alto
FloridaNaples Comprehensive Health, Naples
GeorgiaEmory University, Atlanta
Piedmont Heart Institute, Atlanta
IllinoisNorthwestern, Chicago
MichiganUniversity of Michigan Hospital and Health Systems, Ann Arbor
Henry Ford Health, Detroit
MinnesotaMayo Clinic, Rochester
MissouriSaint Luke's Hospital, Kansas City
New JerseyMorristown Medical Center, Morristown
New YorkNorthwell Health, Manhasset
OhioCleveland Clinic, Cleveland
OhioHealth Research Institute, Columbus
OregonOregon Health & Science Universtiy, Portland
PennsylvaniaUniversity of Pennsylvania, Philadelphia
TennesseeAscension Saint Thomas, Nashville
Vanderbilt University Medical Center, Nashville
WashingtonSwedish Medical Center, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.