TVMR With the Innovalve System Trial - Pilot in Georgia
NCT ID: NCT05682066
Last Updated: 2025-04-23
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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COMPLETED
NA
11 participants
INTERVENTIONAL
2021-12-01
2025-01-01
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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Innovalve TMVR System
MV replacement with Innovalve MR system
Innovalve MR system
Innovalve MR system
Interventions
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Innovalve MR system
Innovalve MR 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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Locations
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Tbilisi Heart and Vascular Clinic
Tbilisi, , Georgia
Countries
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Other Identifiers
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INVL21-01-GE
Identifier Type: -
Identifier Source: org_study_id
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