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
50 participants
INTERVENTIONAL
2025-06-01
2029-10-31
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
Treatment with the inQB8 MonarQ Transcatheter Tricuspid Valve Replacement System
Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve using a transcatheter approach
Interventions
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Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve using a transcatheter approach
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Symptomatic, tricuspid regurgitation (TR) that is severe or greater
* Adequately treated for heart failure based upon medical standards
* Hemodynamically stable
Exclusion Criteria
* Refractory Heart Failure (HF) that requires or required advanced intervention
* Any condition, in the opinion of the investigator, making it unlikely the patient will be able to complete all protocol procedures and follow-up.
* Currently participating in another investigational biologic, drug or device study
18 Years
ALL
No
Sponsors
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inQB8 Medical Technologies, LLC
INDUSTRY
Responsible Party
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Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
Los Robles Hosptial and Medical Center
Thousand Oaks, California, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
North Shore University Hospital
Manhasset, New York, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Baylor Heart Hospital
Plano, Texas, United States
Countries
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Facility Contacts
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Other Identifiers
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CIP-21001
Identifier Type: -
Identifier Source: org_study_id
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