Actively Recruiting
CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
Led by Corcym S.r.l · Updated on 2024-03-06
2150
Participants Needed
52
Research Sites
756 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated approved Informed Consent
- Willing and able to comply with the follow-up schedule of the protocol
- Eligible for treatment with CORCYM aortic, mitral and/or tricuspid products as per the Instructions for Use (IFU)
You will not qualify if you...
- Currently participating in another clinical investigation that could affect the results of this study
- Life expectancy of 12 months or less
- Contraindications to the use of CORCYM aortic, mitral and/or tricuspid devices as outlined in the Instructions for Use (IFU)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 52 locations
1
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
Actively Recruiting
2
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Actively Recruiting
3
Maine Medical Center
Portland, Maine, United States, 04102
Withdrawn
4
Duke University
Durham, North Carolina, United States, 27710
Actively Recruiting
5
East Carolina University
Greenville, North Carolina, United States, 27858
Actively Recruiting
6
University Hospitals Cleveland
Cleveland, Ohio, United States, 44106
Actively Recruiting
7
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
8
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
9
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, United States, 19096
Active, Not Recruiting
10
Innsbruck Medical University
Innsbruck, Austria, 6020
Actively Recruiting
11
Ziekenhuis Oost Limburg
Genk, Belgium, 3600
Actively Recruiting
12
UZ Gent
Ghent, Belgium, 9000
Actively Recruiting
13
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
14
University of Calgary (Foothills Hospital)
Calgary, Canada, 1403
Actively Recruiting
15
Hospital Laval IUCPQ
Québec, Canada, G1V 4G5
Actively Recruiting
16
St. Michael's Hospital
Toronto, Canada, M5B 1W8
Actively Recruiting
17
CHU Clermont-Ferrand_Hopital Gabriel Montpied
Clermont-Ferrand, France, F-63003
Active, Not Recruiting
18
Centre Hospitalier de Lens
Lens, France, 62300
Actively Recruiting
19
CHU Poitiers
Poitiers, France, 86021
Actively Recruiting
20
CHU Toulouse_Rangueil University Hospital
Toulouse, France, 31059
Actively Recruiting
21
Universitätsklinikum Augsburg
Augsburg, Germany, 86156
Active, Not Recruiting
22
Kerckhoff Klinik
Bad Nauheim, Germany, 61231
Actively Recruiting
23
Deutsches Herzzentrum Berlin
Berlin, Germany, 13353
Actively Recruiting
24
Herzzentrum Dresden Universitätsklinik
Dresden, Germany, 1307
Actively Recruiting
25
Universitätsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
26
Universitätsklinikum Magdeburg
Magdeburg, Germany, 39120
Actively Recruiting
27
Klinikum Nürnberg
Nuremberg, Germany, 90471
Actively Recruiting
28
Klinikum Oldenburg GGMBH AöR
Oldenburg, Germany, 26133
Actively Recruiting
29
Ospedale Riuniti Ancona
Ancona, Italy, 60126
Actively Recruiting
30
Policlinico S.Orsola-Malpighi
Bologna, Italy, 40138
Actively Recruiting
31
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy, 25124
Actively Recruiting
32
Ospedale Città di Lecce
Lecce, Italy, 73100
Actively Recruiting
33
Ospedale del Cuore "G. Pasquinucci"
Massa, Italy, 54100
Actively Recruiting
34
IRCCS Policlinico San Donato
Milan, Italy, 20097
Actively Recruiting
35
Azienda ospedaliera dei Colli - Ospedale Monaldi
Naples, Italy, 80131
Actively Recruiting
36
Policlinico Paolo Giaccone
Palermo, Italy, 90127
Actively Recruiting
37
A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Molinette
Torino, Italy, 10126
Actively Recruiting
38
Ospedale Cà Foncello di Treviso
Treviso, Italy, 31100
Actively Recruiting
39
Az. Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste
Trieste, Italy, 34129
Actively Recruiting
40
Ospedale San Bortolo
Vicenza, Italy, 36100
Actively Recruiting
41
Catharina Ziekenhuis
Eindhoven, Netherlands, 5623
Actively Recruiting
42
UMC Groningen
Groningen, Netherlands, 9713
Active, Not Recruiting
43
Hospital de Santa Maria Lisbon
Lisbon, Portugal, 1649-028
Actively Recruiting
44
Dedinje Cardiovascular Institute
Belgrade, Serbia, 11040
Actively Recruiting
45
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
46
Yonsei University Severance Cardiovascular Hospital
Seoul, South Korea, 3722
Actively Recruiting
47
Pusan National University Yangsan Hospital
Yangsan, South Korea, 50612
Actively Recruiting
48
Inselspital, Universitätsspital Bern
Bern, Switzerland, CH-3010
Actively Recruiting
49
Stadtspital Triemli
Zurich, Switzerland, 8063
Actively Recruiting
50
Queen Elisabeth Medical Centre
Birmingham, United Kingdom, B15 2TH
Actively Recruiting
51
Bristol Royal Infirmary
Bristol, United Kingdom, BS2 8HW
Actively Recruiting
52
King's College Hospital
London, United Kingdom, SE5 9RS
Actively Recruiting
Research Team
S
Silvia Dipinto
CONTACT
M
Michela Paroli
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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