New valve offers hope for leaky heart condition
NCT ID NCT05486832
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new device called the Cardiovalve TR system for people with a leaky tricuspid heart valve (tricuspid regurgitation). The goal is to see if the device is safe and can reduce the leak. The study involves 157 participants with moderate to severe symptoms. Researchers will measure how far patients can walk and their quality of life after the procedure.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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157 people
The number who actually took part.
- Started
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Dec 2022
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Functional TR ≥3+ * Symptomatic, NYHA Class II-IVa * Patient approved by the Subject Screening Committee Exclusion Criteria: * Cardiac anatomy deemed not suitable for the Cardiovalve TR system * Hemodynamic instability * Severe right ventricular failure * Refractory heart failure requiring advanced intervention
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Charité university
Berlin, 10117, Germany
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Herzzentrum Uniklinik
Cologne, 50937, Germany
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Uniklinik Bonn
Bonn, 53127, Germany
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University Heart Center Lübeck
Lübeck, 20251, Germany
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Universitäres Herz
Hamburg, 20251, Germany
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Universität Bochum
Bad Oeynhausen, 32545, Germany
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Universitätsklinikum - Regensburg
Regensburg, 93053, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Lung and liver scans could map hidden heart valve disease
- Jugular vein approach tested for replacing leaky heart valve without open surgery
- Pacemaker showdown: which device spares the Heart's valve?
- Can a tiny heart implant fix a leaky valve without surgery?
- Can a catheter valve replace Open-Heart surgery for a leaky heart valve?
- A new Catheter-Based valve could fix a leaky heart valve without surgery