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CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
Sponsor: Corcym S.r.l
Summary
MANTRA is a prospective, multiple-arm, multi-center, global, post-market clinical follow-up study. The main objective is to monitor ongoing safety and performance of the CORCYM devices and accessories used for aortic, mitral and tricuspid valvular diseases in a real-world setting. Corcym S.r.l., is a medical device manufacturer with a broad product portfolio for cardiac surgeons, offering solutions for the treatment of aortic, mitral and tricuspid valve disease. The MANTRA Master Plan (Master Protocol) is intended as an overarching Umbrella Protocol that allows multiple sub-studies to be added, as needed. The Umbrella Master Protocol concept offers an excellent solution to provide post-marketing clinical follow-up information on the entire cardiac surgery heart valve portfolio of the sponsor in a common database, including corelab assessment of hemodynamic and structural performance, annular motion and Dynamics for one of the products. Currently, three sub-studies are planned: * MANTRA - Aortic Sub-Study * MANTRA - Mitral/Tricuspid Sub-Study (Excluding Memo 4D) * MANTRA - Memo 4D Sub-Study
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
2150
Start Date
2021-06-29
Completion Date
2035-12-31
Last Updated
2024-03-06
Healthy Volunteers
No
Conditions
Locations (52)
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
Duke University
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
University Hospitals Cleveland
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States
Innsbruck Medical University
Innsbruck, Austria
Ziekenhuis Oost Limburg
Genk, Belgium
UZ Gent
Ghent, Belgium
UZ Leuven
Leuven, Belgium
University of Calgary (Foothills Hospital)
Calgary, Canada
Hospital Laval IUCPQ
Québec, Canada
St. Michael's Hospital
Toronto, Canada
CHU Clermont-Ferrand_Hopital Gabriel Montpied
Clermont-Ferrand, France
Centre Hospitalier de Lens
Lens, France
CHU Poitiers
Poitiers, France
CHU Toulouse_Rangueil University Hospital
Toulouse, France
Universitätsklinikum Augsburg
Augsburg, Germany
Kerckhoff Klinik
Bad Nauheim, Germany
Deutsches Herzzentrum Berlin
Berlin, Germany
Herzzentrum Dresden Universitätsklinik
Dresden, Germany
Universitätsklinikum Essen
Essen, Germany
Universitätsklinikum Magdeburg
Magdeburg, Germany
Klinikum Nürnberg
Nuremberg, Germany
Klinikum Oldenburg GGMBH AöR
Oldenburg, Germany
Ospedale Riuniti Ancona
Ancona, Italy
Policlinico S.Orsola-Malpighi
Bologna, Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy
Ospedale Città di Lecce
Lecce, Italy
Ospedale del Cuore "G. Pasquinucci"
Massa, Italy
IRCCS Policlinico San Donato
Milan, Italy
Azienda ospedaliera dei Colli - Ospedale Monaldi
Naples, Italy
Policlinico Paolo Giaccone
Palermo, Italy
A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Molinette
Torino, Italy
Ospedale Cà Foncello di Treviso
Treviso, Italy
Az. Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste
Trieste, Italy
Ospedale San Bortolo
Vicenza, Italy
Catharina Ziekenhuis
Eindhoven, Netherlands
UMC Groningen
Groningen, Netherlands
Hospital de Santa Maria Lisbon
Lisbon, Portugal
Dedinje Cardiovascular Institute
Belgrade, Serbia
Seoul National University Hospital
Seoul, South Korea
Yonsei University Severance Cardiovascular Hospital
Seoul, South Korea
Pusan National University Yangsan Hospital
Yangsan, South Korea
Inselspital, Universitätsspital Bern
Bern, Switzerland
Stadtspital Triemli
Zurich, Switzerland
Queen Elisabeth Medical Centre
Birmingham, United Kingdom
Bristol Royal Infirmary
Bristol, United Kingdom
King's College Hospital
London, United Kingdom