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
80 participants
INTERVENTIONAL
2024-08-29
2030-12-30
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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Transcatheter Tricuspid Valve Replacement
Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System
Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Interventions
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Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
* Institutional Heart Team evaluates patient as being at increased operative risk
Exclusion Criteria
* Patient who is hemodynamically unstable
* Anatomical contraindications for implantation with study device
* Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
18 Years
ALL
No
Sponsors
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TRiCares
INDUSTRY
Responsible Party
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Principal Investigators
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Jörg Hausleiter, MD
Role: PRINCIPAL_INVESTIGATOR
LMU Munich
Locations
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Algemeen Stedelijk Ziekenhuis
Aalst, , Belgium
ZNA Middelheim
Antwerp, , Belgium
UZ Brussel
Brussels, , Belgium
Cliniques Universitaires Saint-Luc UCL
Brussels, , Belgium
Centre hospitalier universitaire CHU de Liège
Liège, , Belgium
AZ Delta
Roeselare, , Belgium
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, , Germany
Ludwig Maximilian University Hospital
Munich, , Germany
Countries
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Central Contacts
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Facility Contacts
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Stefan Verheye, MD
Role: primary
Stijn Lochy, MD
Role: primary
Joelle Kefer, MD
Role: primary
Patrizio Lancellotti, MD
Role: primary
Maarten Vanhaverbeke, MD
Role: primary
Phiipp Lurz, MD
Role: primary
Jörg Hausleiter, MD
Role: primary
Other Identifiers
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2401
Identifier Type: -
Identifier Source: org_study_id
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