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TVMR With the INNOVALVE System Trial - Early Feasibility Study

RECRUITINGN/ASponsored by Edwards Lifesciences
Actively Recruiting
PhaseN/A
SponsorEdwards Lifesciences
Started2022-09-01
Est. completion2026-07-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations17 sites
View on ClinicalTrials.gov →

NCT04919980

Summary

Study to evaluate the safety and performance of the INNOVALVE system

Eligibility

Age: 18 Years+Healthy volunteers accepted
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%

Conditions2

Heart DiseaseMitral Valve Regurgitation (Degenerative or Functional)

Locations17 sites

Cedars-Sinai
Los Angeles, California, 90048
Mitch Gheorghiu310-407-9553Mitch.Gheorghiu@cshs.org
Naples Comprehensive Health
Naples, Florida, 34102
Kathy Byrd239-624-8113kathy.byrd@nchmd.org
Piedmont Heart Institute
Atlanta, Georgia, 30309
Jennifer Bolivar Aldana770-846-0344jennifer.bolivaraldana@piedmont.org
Northwestern
Chicago, Illinois, 60611
BCVI Clinical Trials Unit312-926-4000heartresearch@northwestern.edu
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, 48109
Keoni Fordham734-763-6551fordham@med.umich.edu

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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