New valve replacement offers hope for heart leak patients who can't have standard surgery
NCT ID NCT05496998
First seen Jun 27, 2026 · Last updated Jul 07, 2026 · Updated 2 times
Summary
This study tests a new device (Intrepid TMVR) to replace the mitral valve in people with severe mitral regurgitation (leaky heart valve) who are not candidates for standard surgery or repair. About 400 participants will receive the device and be followed for safety and effectiveness. The goal is to see if the device can stop or greatly reduce the backward blood flow and improve survival.
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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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Study contacts
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Aarhus University Hospital
RECRUITINGAarhus, 8200, Denmark
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Azienda Ospedaliera Spedali Civili di Brescia
RECRUITINGBrescia, 25123, Italy
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Azienda Ospedaliero - Universitaria di Bologna - Policlinico S.Orsola Malpighi
RECRUITINGBologna, 40138, Italy
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Azienda Ospedaliero Universitaria Pisana
RECRUITINGPisa, 56124, Italy
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CHRU de Tours
RECRUITINGTours, 37044, France
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CHU Bordeaux
RECRUITINGBordeaux, Pessac Cedex, 33600, France
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CHU Rennes - Pontchaillou Hospital
RECRUITINGRennes, 35033, France
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CHU Timone
RECRUITINGMarseille, 13385, France
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CHU de Nantes
RECRUITINGNantes, 44093, France
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Catharina Hospital
RECRUITINGEindhoven, 5623 EJ, Netherlands
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Central University Hospital of Asturias
RECRUITINGOviedo, 33011, Spain
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Centre Cardiologique du Nord (CCN)
RECRUITINGSaint-Denis, 93200, France
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Clinique Pasteur
RECRUITINGToulouse, Cedex 03, 31076, France
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Deutsches Herzzentrum München
RECRUITINGMünchen, 80636, Germany
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Deutsches Herzzentrum der Charité (DHZC)
RECRUITINGBerlin, 13353, Germany
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Erasmus University Medical Center
RECRUITINGRotterdam, 3015 AA, Netherlands
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Guys & St Thomas NHS Foundation Trust - St Thomas Hospital London
RECRUITINGLondon, SE1 7EH, United Kingdom
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Heart and Diabetes Center NRW
RECRUITINGBad Oeynhausen, 32545, Germany
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Henri-Mondor University Hospital
RECRUITINGCréteil, 94000, France
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Herzzentrum Leipzig
RECRUITINGLeipzig, 04289, Germany
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Hospital Clínic de Barcelona
RECRUITINGBarcelona, 08036, Spain
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Hospital Universitario Ramón y Cajal
RECRUITINGMadrid, 28034, Spain
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IRCCS Policlinico San Donato
RECRUITINGSan Donato Milanese, 20097, Italy
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LMU Clinic of University Hospital München
RECRUITINGMünchen, 81377, Germany
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Leeds General Infirmary
RECRUITINGLeeds, LS1 3EX, United Kingdom
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Odense University Hospital
RECRUITINGOdense, 5000, Denmark
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Ospedale San Raffaele
RECRUITINGMilan, 20132, Italy
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Rigshospitalet
RECRUITINGCopenhagen, 2100, Denmark
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Royal Brompton Hospital
RECRUITINGLondon, SW3 6NP, United Kingdom
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St. Antonius Hospital
RECRUITINGNieuwegein, 3435 CM, Netherlands
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University Hospital Alvaro Cunqueiro
RECRUITINGVigo, 36312, Spain
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University Hospitals Sussex NHS Foundation Trust
RECRUITINGBrighton, BN2 5BE, United Kingdom
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University Medical Center Mainz
RECRUITINGMainz, 55131, Germany
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Universitäres Herz- und Gefäßzentrum Hamburg
RECRUITINGHamburg, 20246, Germany
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Universitätsklinikum Bonn
RECRUITINGBonn, 53127, Germany
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Universitätsklinikum Ulm
RECRUITINGUlm, 89081, Germany
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Universitätsspital Bern
RECRUITINGBern, 3010, Switzerland
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More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New heart valve device could spare High-Risk patients from Open-Heart surgery
- First-in-Human trial aims to offer new hope for patients with leaky heart valves who Can't have surgery
- Wireless sensor could help doctors Fine-Tune heart failure treatment in real time
- Tiny device could fix leaky heart valves without cutting chest open
- Artificial intelligence could make heart valve surgery safer and more precise
- Experimental heart valve device tested in just one patient — study halted