New heart valve fix without open surgery shows promise in High-Risk patients
NCT ID NCT03039855
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new device called the Tiara valve, which is implanted through a small tube in the chest to replace the leaky mitral valve without open-heart surgery. It enrolled 157 people with severe mitral regurgitation who were considered too high-risk for traditional surgery. The main goals were to see if the device could safely reduce the valve leakage and improve survival and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
Tiara mitral valve and delivery system (a device implanted via a tube through the chest to replace the leaky heart valve)
What this could lead to
If it works, this could offer a less invasive option for people with severe mitral regurgitation who are too high-risk for open-heart surgery.
What could go wrong
This is a completed early-stage study without a control group, so results may not apply to all patients. Device implantation carries risks like bleeding, infection, or valve failure.
Disclaimer
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This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
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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
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Locations
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Deutches Herzzentrum Berlin
Berlin, 13353, Germany
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Edinburgh Heart Centre Royal Infirmary
Edinburgh, EH16 4SA, United Kingdom
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Fondazione Policlinico Universitario A. Gemelli - Università Cattolica del Sacro Cuore.
Roma, RM, 00168, Italy
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Fondazione Toscana 'Gabriele Monasterio'
Massa, 54100, Italy
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Herz- und Diabeteszentrum NRW
Bad Oeynhausen, 32545, Germany
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Herz-Kreislauf-Zentrum Klinikum Hersfeld Rotenburg
Rotenburg an der Fulda, Germany
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Herzzentrum Leipzig
Leipzig, 04289, Germany
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Hospital Clinico San Carlos
Madrid, 28040, Spain
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IRCCS Policlinico San Donato
San Donato Milanese, 20097, Italy
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Immanuel Klinikum Bernau und Herzzentrum Brandenburg
Bernau, 16321, Germany
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Kerckhoff Klinik Herzzentrum-Herzchirurgie
Bad Nauheim, 61231, Germany
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King's College Hospital
London, SE59RS, United Kingdom
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Ospedale San Raffaele
Milan, 20132, Italy
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Sana Herzchirurgie Stuttgart GmbH
Stuttgart, 70174, Germany
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Schüchtermann-Klinik
Bad Rothenfelde, 49214, Germany
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St. Antonius Hospital
Nieuwegein, Netherlands
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St.-Johannes-Hospital, Klinik für Innere Medizin I
Dortmund, 44229, Germany
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Tel Aviv Medical Center
Tel Aviv, Israel
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Universitasklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
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Universitätsklinikum Halle
Halle, 06120, Germany