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TVMR With the INNOVALVE System Trial - Early Feasibility Study

RecruitingNAAges 18 Years - anyAllEdwards Lifesciences
NCT04919980 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Study to evaluate the safety and performance of the INNOVALVE system

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📋 Eligibility rules (as published)
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%
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What it tests

  • INNOVALVE system
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Where

21 sites
Cedars-Sinai
Los Angeles, United States
Stanford University
Palo Alto, United States
Naples Comprehensive Health
Naples, United States
Emory University
Atlanta, United States
Piedmont Heart Institute
Atlanta, United States
Northwestern
Chicago, United States
University of Michigan Hospital and Health Systems
Ann Arbor, United States
Henry Ford Health
Detroit, United States

…and 13 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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