CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
NCT ID: NCT05002543
Last Updated: 2024-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2150 participants
OBSERVATIONAL
2021-06-29
2035-12-31
Brief Summary
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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
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Detailed Description
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Currently, three substudies are planned:
* MANTRA - Aortic Sub-Study
* MANTRA - Mitral/Tricuspid Sub-Study (excluding Memo 4D)
* MANTRA - Memo 4D Sub-Study
The aim of the studies assembled under the master protocol is the continued collection of safety and performance data during heart valve procedures and the relevant follow-up visits in subjects where any of the CORCYM devices and accessories are used in a real-world setting, in accordance with the IFUs, and at the discretion of the investigator.
MANTRA study is expected to enroll approximately 2150 subjects in up to 130 sites worldwide:
* Approximately 1650 subjects considered suitable for treatment with a CORCYM aortic device
* Approximately 300 subjects considered suitable for treatment with a CORCYM mitral and/or tricuspid device (excluding Memo 4D)
* Approximately 200 subjects considered suitable for treatment with Memo 4D
Expected enrollment duration may vary across the different projects. Subject follow-up is planned at discharge, 30 days after implantation and then annually up to 10 years. Sites can choose to participate in one or more sub-studies.
All available data shall be gathered during standard medical care.
At a minimum, the following data will be collected:
* Informed Consent
* Screening/Baseline data, including demographics and medical history
* Procedural data
* Hospitalization and Discharge data
* Follow-up data: 30 days and annually up to 10 years post procedure
* Serious Adverse Event and Device Deficiencies information
As part of the study, the subject will be asked to complete quality of life questionnaire(s) at baseline, 30 days and at 1-year follow-up.
In addition, for the MEMO 4D sub-study only, an Echocardiography Core Laboratory has been appointed by the Sponsor to assess the hemodynamic and structural performance, annular motion and dynamics, and 3D echocardiogram images (transesophageal during the procedure and transthoracic during follow up) will be collected for Corelab readings.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MANTRA Aortic Sub-study
Subjects diagnosed with aortic valve disease who are considered suitable to undergo aortic valve replacement with a CORCYM device can be included in this study.
The following devices can be entered in the study:
Tissue Valve:
* Perceval® PLUS SUTURELESS AORTIC HEART VALVE
* Perceval® S SUTURELESS AORTIC HEART VALVE
Mechanical Valves:
* Bicarbon™ Bileaflet Heart Valve Prostheses Models:
* Bicarbon Fitline Aortic (LFA)
* Bicarbon Slimline Aortic (LSA)
* Bicarbon Overline Aortic (LOV)
* Carbomedics Prosthetic Heart Valve Models:
* Standard Aortic Valve
* Reduced Aortic Valve
* Supra-Annular Aortic Valve (Top Hat)
* Orbis™ Aortic Valve
Ascending Aorta Prostheses
* CARBOMEDICS-CARBO-SEAL™
* CARBOMEDICS CARBO-SEAL™ VALSALVA
No interventions assigned to this group
MANTRA Mitral/Tricuspid Sub-study
Subjects diagnosed with mitral and/or tricuspid valve disease who are considered suitable to undergo mitral valve repair/replacement and/or tricuspid valve repair with a CORCYM device can be included in this study.
The following devices can be entered in the study:
Annuloplasty Rings:
* SOVERING™ ANNULOPLASTY DEVICE models
* annuloplasty ring, mitral model
* annuloplasty band, mitral and tricuspid models
* Carbomedics Annuloplasty Ring models:
* CARBOMEDICS ANNULOFLO®
* CARBOMEDICS ANNULOFLEX®
* Memo Annuloplasty Ring o MEMO 3D™ SEMIRIGID ANNULOPLASTY RING
Mitral Valves:
* Bicarbon™ Bileaflet Heart Valve Prostheses Models:
o Bicarbon Fitline Mitral (LFM)
* Carbomedics Prosthetic Heart Valve Models:
* Standard Mitral Valve
* Orbis™ Mitral Valve
* OptiForm® Mitral Valve
No interventions assigned to this group
MANTRA Memo 4D Sub-study
Subjects diagnosed with mitral valve disease who are considered suitable to undergo mitral valve repair with a CORCYM Memo 4D annuloplasty ring can be included in this study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject is 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 outlined in the applicable Instructions for Use (IFU)
Exclusion Criteria
* Subject has a life expectancy ≤ 12 months
* Subject has contraindications to the use of CORCYM aortic, mitral and/or tricuspid devices as outlined in the applicable Instructions For Use (IFU)
ALL
No
Sponsors
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Corcym S.r.l
INDUSTRY
Responsible Party
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Principal Investigators
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Sara Gaggianesi
Role: STUDY_DIRECTOR
Corcym S.r.l
Locations
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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
Napoli, , 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
Countries
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Central Contacts
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Facility Contacts
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References
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Dzemali O, Rodriguez Cetina Biefer H, Di Eusanio M, Fabre O, Troise G, Bonaros N, Grimaldi F, Choi YH, Santarpino G, Baeza C, Pollari F, Marcheix B, Pacini D, Argano V, Baghai M, Bhabra M, Mazzaro E, Badano L, Kempfert J. Mitral valve repair with the semi-rigid Memo 4D annuloplasty ring: early clinical and echocardiographic outcomes from the MANTRA study. Interdiscip Cardiovasc Thorac Surg. 2024 Dec 25;40(1):ivae208. doi: 10.1093/icvts/ivae208.
Micovic S, Nobre A, Choi JW, Solinas M, Shehada SE, Torella M, Baeza C, Parrino E, Pollari F, Troise G, Kappert U, Mellert F, Je HG, Argano V, Lam KY, Rinaldi M, Gutermann H, Meuris B; MANTRA Investigators. Early outcomes of aortic valve replacement with Perceval PLUS sutureless valve: results of the prospective multicentric MANTRA study. J Cardiothorac Surg. 2024 Jun 21;19(1):340. doi: 10.1186/s13019-024-02861-1.
Other Identifiers
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LNH800
Identifier Type: -
Identifier Source: org_study_id
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