New heart valve device offers hope for patients too sick for surgery
NCT ID NCT05496998
First seen Nov 18, 2025 · Last updated May 15, 2026 · Updated 16 times
Summary
This study tests a new device called the Medtronic Intrepid™ system to replace the mitral valve in people with severe mitral regurgitation (a leaky heart valve). The device is placed through a tube in the leg, avoiding open-heart surgery. The study will enroll 400 people whose heart team says they cannot have standard repair or surgery. The main goals are to see if the device is safe (how many people survive at one year) and if it works (how many have little or no leak at 30 days).
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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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Contacts and locations
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Study contacts
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Contact
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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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Conditions
Explore the condition pages connected to this study.