TVMR With the INNOVALVE System Trial - Early Feasibility Study
NCT ID: NCT04919980
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
65 participants
INTERVENTIONAL
2022-09-01
2031-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
MV replacement with INNOVALVE system
INNOVALVE system
INNOVALVE system
Interventions
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INNOVALVE system
INNOVALVE system
Eligibility Criteria
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Inclusion Criteria
* High risk for open-heart surgery
* Meets anatomical criteria
Exclusion Criteria
* Patient is inoperable
* EF\<25%
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Chet Rihal
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic
Locations
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Cedars-Sinai
Los Angeles, California, United States
Naples Comprehensive Health
Naples, Florida, United States
Piedmont Heart Institute
Atlanta, Georgia, United States
Northwestern
Chicago, Illinois, United States
University of Michigan Hospital and Health Systems
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Morristown Medical Center
Morristown, New Jersey, United States
Northwell Health
Manhasset, New York, United States
Cornell
New York, New York, United States
NewYork-Presbyterian / Columbia University
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
OhioHealth Research Institute
Columbus, Ohio, United States
Oregon Health & Science Universtiy
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Ascension Saint Thomas
Nashville, Tennessee, United States
Swedish Medical Center
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-13
Identifier Type: -
Identifier Source: org_study_id
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