"TARGET Study": Safety and Performance of the Cardiovalve TR Replacement System
NCT ID: NCT05486832
Last Updated: 2026-01-05
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
100 participants
INTERVENTIONAL
2022-12-09
2033-12-15
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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Cardiovalve TR replacement Group
Cardiovalve TR valve replacement System
Cardiovalve TR valve replacement System
The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.
Interventions
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Cardiovalve TR valve replacement System
The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.
Eligibility Criteria
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Inclusion Criteria
* Symptomatic, NYHA Class II-IVa
* Patient approved by the Subject Screening Committee
Exclusion Criteria
* Hemodynamic instability
* Severe right ventricular failure
* Refractory heart failure requiring advanced intervention
18 Years
85 Years
ALL
No
Sponsors
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Cardiovalve Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Georg Nickenig, Dr
Role: PRINCIPAL_INVESTIGATOR
Bonn Clinic
Locations
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Universität Bochum
Bad Oeynhausen, , Germany
Charité university
Berlin, , Germany
Uniklinik Bonn
Bonn, , Germany
Herzzentrum Uniklinik
Cologne, , Germany
Universitäres Herz
Hamburg, , Germany
University Heart Center Lübeck
Lübeck, , Germany
Universitätsklinikum - Regensburg
Regensburg, , Germany
Countries
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Central Contacts
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Facility Contacts
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Rudolph Volker, MD
Role: primary
Sherif Mohammad, MD
Role: primary
Georg Nickenig, MD
Role: primary
Adam Matti, MD
Role: primary
Niklas Schofer, MD
Role: primary
Christian. Frerker, MD
Role: primary
Michael Hilker, MD
Role: primary
Other Identifiers
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CP-21-01
Identifier Type: -
Identifier Source: org_study_id
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