RecruitingNot ApplicableNCT04919980
TVMR With the INNOVALVE System Trial - Early Feasibility Study
Sponsor
Edwards Lifesciences
Enrollment
65 participants
Start Date
Sep 1, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
Study to evaluate the safety and performance of the INNOVALVE system
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- Clinically significant, symptomatic mitral regurgitation
- High risk for open-heart surgery
- Meets anatomical criteria
Exclusion Criteria3
- Unsuitable anatomy
- Patient is inoperable
- EF<25%
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Interventions
DEVICEINNOVALVE system
INNOVALVE system
Locations(17)
View Full Details on ClinicalTrials.gov
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NCT04919980