TVMR With the Innovalve System Trial - Pilot Study in Italy
NCT ID: NCT05010746
Last Updated: 2025-06-26
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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ACTIVE_NOT_RECRUITING
NA
4 participants
INTERVENTIONAL
2023-01-24
2029-10-04
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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MV replacement with Innovalve MR system
MV replacement with Innovalve MR system
Innovalve TMVR system
Innovalve TMVR system
Interventions
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Innovalve TMVR system
Innovalve TMVR system
Eligibility Criteria
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Inclusion Criteria
* High risk for open-heart surgery
* Meets anatomical criteria
Exclusion Criteria
* Patient is inoperable
* EF \<30%
18 Years
ALL
No
Sponsors
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Edwards Lifesciences
INDUSTRY
Responsible Party
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Principal Investigators
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Antonio Colombo, Prof
Role: PRINCIPAL_INVESTIGATOR
Humanitas IRCCS
Locations
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Humanitas
Milan, , Italy
Countries
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Other Identifiers
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INVL20-01-IT
Identifier Type: -
Identifier Source: org_study_id
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