Cardiac Valve DiseaseMANTRANCT05002543
CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
An observational study of Cardiac Valve Disease, run by Corcym S.r.l at 52 sites in 13 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiac Valve Disease
- How many people
- 2,150 participants
- Where
- 52 sitesin 13 countries
- Study dates
- 29 Jun 2021to 31 Dec 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects diagnosed with heart valve disease who are considered suitable to undergo heart valve replacement/repair with a CORCYM device can be included
Who may be able to join
- Signed and dated approved Informed Consent
- 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)
Who cannot join
- Subject is already participating to another clinical investigation that could confound the results of this clinical investigation.
- 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)
Trial locations and contacts
52 sites in 13 countries. Contact the study team or a site near you to ask about taking part.
52 sites in 13 countries
Italy12 sites, 12 recruiting
- Recruiting
Ospedale Riuniti Ancona
Ancona, 60126
Marco Di Eusanio, m.dieusanio@staff.univpm.it
- Recruiting
Policlinico S.Orsola-Malpighi
Bologna, 40138
Davide Pacini, davide.pacini@unibo.it
- Recruiting
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, 25124
Giovanni Troise, giovanni.troise@poliambulanza.it
- Recruiting
Ospedale Città di Lecce
Lecce, 73100
Giuseppe Santarpino, MD, +39 080 5644462, gsantarpino@gvmnet.it
- Recruiting
Ospedale del Cuore "G. Pasquinucci"
Massa, 54100
Marco Solinas, marco.solinas@ftgm.it
- Recruiting
IRCCS Policlinico San Donato
Milan, 20097
Francesco Grimaldi, francesco.grimaldi@grupposandonato.it
- Recruiting
Azienda ospedaliera dei Colli - Ospedale Monaldi
Naples, 80131
Micheke Torella, michele.torella@unicampania.it
- Recruiting
Policlinico Paolo Giaccone
Palermo, 90127
Vincenzo Argano, vargano@hotmail.com
- Recruiting
A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Molinette
Torino, 10126
Mauro Rinaldi, mauro.rinaldi@unito.it
- Recruiting
Ospedale Cà Foncello di Treviso
Treviso, 31100
Giuseppe Minniti, giuseppe.minniti@aulss2.veneto.it
- Recruiting
Az. Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste
Trieste, 34129
Enzo Mazzaro, enzo.mazzaro@asugi.sanita.fvg.it
- Recruiting
Ospedale San Bortolo
Vicenza, 36100
Loris Salvador, loris.salvador@aulss8.veneto.it
United States9 sites, 7 recruiting
- Recruiting
University Hospitals Cleveland
Cleveland, Ohio, 44106
Christian Baeza, cristian.baeza@uhhospitals.org
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Eric Roselli, ROSELLE@ccf.org
- Recruiting
Duke University
Durham, North Carolina, 27710
G. Chad Hughes, gchad.hughes@duke.edu
- Recruiting
East Carolina University
Greenville, North Carolina, 27858
Michael Bates, batesm19@ecu.edu
- Recruiting
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290
David Heimansohn, david.heimansohn@ascension.org
- Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Eugene Parrino, eparrino@ochsner.org
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Joseph Bavaria, joseph.bavaria@pennmedicine.upenn.edu
- Withdrawn
Maine Medical Center
Portland, Maine, 04102
- Active, not recruiting
Lankenau Institute for Medical Research
Wynnewood, Pennsylvania, 19096
Germany8 sites, 7 recruiting
- Active, not recruiting
Universitätsklinikum Augsburg
Augsburg, 86156
- Recruiting
Kerckhoff Klinik
Bad Nauheim, 61231
Yeong-Hoon Choi, Y.Choi@kerckhoff-klinik.de
- Recruiting
Deutsches Herzzentrum Berlin
Berlin, 13353
Jörg Kempfert, kempfert@dhzb.de
- Recruiting
Herzzentrum Dresden Universitätsklinik
Dresden, 1307
Utz Kappert, utz.kappert@herzzentrum-dresden.com
- Recruiting
Universitätsklinikum Essen
Essen, 45147
Sharaf-Eldin Shehada, sharaf-eldin.shehada@uk-essen.de
- Recruiting
Universitätsklinikum Magdeburg
Magdeburg, 39120
George Awad, george.awad@med.ovgu.de
- Recruiting
Klinikum Nürnberg
Nuremberg, 90471
Francesco Pollari, francesco.pollari@klinikum-nuernberg.de
- Recruiting
Klinikum Oldenburg GGMBH AöR
Oldenburg, 26133
Friedrich Mellert, Mellert.friedrich@klinikum-oldenburg.de
France4 sites, 3 recruiting
- Active, not recruiting
CHU Clermont-Ferrand_Hopital Gabriel Montpied
Clermont-Ferrand, F-63003
- Recruiting
Centre Hospitalier de Lens
Lens, 62300
Olivier Fabre, ofabre@ch-lens.fr
- Recruiting
CHU Poitiers
Poitiers, 86021
Pierre Corbi, Pierre.CORBI@chu-poitiers.fr
- Recruiting
CHU Toulouse_Rangueil University Hospital
Toulouse, 31059
Bertrand Marcheix, marcheix.b@chu-toulouse.fr
Belgium3 sites, 3 recruiting
- Recruiting
Ziekenhuis Oost Limburg
Genk, 3600
Herbert Gutermann, Herbert.Gutermann@ZOL.BE
- Recruiting
UZ Gent
Ghent, 9000
Thierry Bové, Thierry.Bove@uzgent.be
- Recruiting
UZ Leuven
Leuven, 3000
Bart Meuris, bart.meuris@uzleuven.be
Canada3 sites, 3 recruiting
- Recruiting
University of Calgary (Foothills Hospital)
Calgary, 1403
William Kent, William.Kent@albertahealthservices.ca
- Recruiting
Hospital Laval IUCPQ
Québec, G1V 4G5
Pierre Voisine, pierre.voisine@criucpq.ulaval.ca
- Recruiting
St. Michael's Hospital
Toronto, M5B 1W8
Gianluigi Bisleri, gianluigi.bisleri@unityhealth.to
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jae Woong Choi, cjw01@snu.ac.kr
- Recruiting
Yonsei University Severance Cardiovascular Hospital
Seoul, 3722
Seung Hyun Lee, henry75@yuhs.ac
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, 50612
Hyung Gon Je, jehg7332@gmail.com
United Kingdom3 sites, 3 recruiting
- Recruiting
Queen Elisabeth Medical Centre
Birmingham, B15 2TH
Moninder Bhabra, Moninder.Bhabra@uhb.nhs.uk
- Recruiting
Bristol Royal Infirmary
Bristol, BS2 8HW
Cha Rajakaruna, cha.rajakaruna@uhbw.nhs.uk
- Recruiting
King's College Hospital
London, SE5 9RS
Max Baghai, mbaghai@nhs.net
Netherlands2 sites, 1 recruiting
- Recruiting
Catharina Ziekenhuis
Eindhoven, 5623
Kayan Lam, kayan.lam@catharinaziekenhuis.nl
- Active, not recruiting
UMC Groningen
Groningen, 9713
Switzerland2 sites, 2 recruiting
- Recruiting
Inselspital, Universitätsspital Bern
Bern, CH-3010
Matthias Siepe, matthias.siepe@insel.ch
- Recruiting
Stadtspital Triemli
Zurich, 8063
Omer Dzemali, Omer.Dzemali@triemli.zuerich.ch
Austria1 site, 1 recruiting
- Recruiting
Innsbruck Medical University
Innsbruck, 6020
Nikolaos Bonaros, nikolaos.bonaros@i-med.ac.at
Portugal1 site, 1 recruiting
- Recruiting
Hospital de Santa Maria Lisbon
Lisbon, 1649-028
Angelo Nobre, angelolucasnobre@gmail.com
Serbia1 site, 1 recruiting
- Recruiting
Dedinje Cardiovascular Institute
Belgrade, 11040
Slobodan Micovic, boban.mic@gmail.com
About this study
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.
Read more
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
Read the detailed description
The MANTRA Master Plan (Master Protocol) is intended as an overarching Umbrella Protocol that allows multiple substudies 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.
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
- Cardiac Valve Disease
- Keywords
- Aortic Valve Replacement, Mitral Valve Replacement, Mitral Valve Repair, Tricuspid Valve Repair
- Medical subject headings
- Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| 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 | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success
Device success at 30 days (+14 days) based on VARC-3, defined as:
- Technical success
- Freedom from mortality
- Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication
- Intended performance of the valve (mean gradient<20 mmHg and less than moderate aortic regurgitation)
The number and percentage of subjects with device success at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.
Measured: 30 days
The primary endpoint in the MITRAL/TRICUSPID Sub-study is number and percentage of subjects with Device Success
Device success at 30 days (+14 days) based on MVARC, defined as:
- Procedural mortality or stroke AND
- Proper placement and positioning of the device AND
- Freedom from unplanned surgical or interventional procedures related to the device or access procedure AND
- Continued intended safety and performance of the device, including:
- Evidence of structural or functional failure
- Specific device-related technical failure issues and complications
- MITRAL: Reduction of Mitral Regurgitation (MR) to either optimal or acceptable levels (site-reported)
- TRICUSPID: Reduction of Tricuspid Regurgitation (TR) to either optimal or acceptable levels (site-reported)
Number and percentage of subjects with device success, along with individual component, will be presented.
Measured: 30 days
The primary endpoint in the MEMO 4D Sub-study is number and percentage of subjects with Device Success
Device success at 30 days (+14 days) based on the MVARC, defined as:
- Procedural mortality or stroke; AND
- Proper placement and positioning of the device; AND
- Freedom from unplanned surgical or interventional procedures related to the device or access procedure; AND
- Continued intended safety and performance of the device, including:
- Evidence of structural or functional failure
- Specific device-related technical failure issues and complications
- Reduction of Mitral Regurgitation (MR) to either optimal or acceptable levels without significant mitral stenosis (i.e., post-procedure EOA is ≥ 1.5 cm2 with a transmitral gradient <5 mmHg), and with no greater than mild MR core-lab assessed
The number and percentage of subjects with device success at 30 days as per MVARC definition, along with individual component of the success, will be presented.
Measured: 30 days
Secondary outcomes (10)
Mortality (all-cause mortality, cardiovascular mortality, device related mortality)
Number of patients with this event
Measured: up to 10 years from implant
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE - composite endpoint of all cause death, myocardial infarction, stroke, and valve re-intervention)
Number of patients with this event
Measured: up to 10 years from implant
Re-hospitalization (all-cause re-hospitalization, cardiovascular re-hospitalization, device related re-hospitalization)
Number of patients with this event
Measured: up to 10 years from implant
Technical success
Technical success, defined as successful delivery, correct positioning and deployment of the first intended device intraoperatively
Measured: intraoperatively
Clinical Efficacy (AORTIC sub-study)
Clinical Efficacy according to VARC-3 guidelines
Measured: 12 months
Valve-related long-term clinical efficacy
Valve-related long-term clinical according to VARC-3 guidelines
Measured: at 5 years and up to 10 years
Bioprosthetic Valve Dysfunction (BVD), including Structural Valve Deterioration (SVD), Non structural valve dysfunction (NSVD), Thrombosis and Endocarditis
Number of patients with this event
Measured: up to 10 years from implant
Patient outcome (Kansas City Cardiomyopathy Questionnaire (KCCQ-12); and EQ-5D-5L (in patients treated with Perceval Plus)
Quality of life improvement from baseline up to 12 months
Measured: 12 months
Patient outcome (New York Heart Association (NYHA) Classification)
Change of New York Heart Association (NYHA) functional class from baseline up to 12 months after implant, and at each subsequent follow-up
Measured: up to 10 years from implant
Hemodynamic and structural performance
Main hemodynamic parameters will be collected according to the different indications (Aortic, Mitral and Tricuspid)
Measured: up to 10 years from implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start29 Jun 2021
- Primary completion30 Aug 2025 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac Valve DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,150 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Corcym S.r.l
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sara Gaggianesi, Study director, Corcym S.r.l
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002543
- Sponsor's protocol ID
- LNH800
- Acronym
- MANTRA
- Status last verified
- Mar 2024
- First submitted
- 26 Jul 2021
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Santarpino G, Lorusso R, Di Mauro M, D'Anna V, Prencipe CM, Voisine P, Bisleri G, Parrino E, Bates M, Hughes GC, Roselli E, Baeza C, Heimansohn D, Bove T, Meuris B, Gutermann H, Corbi P, Pollari F, Awad G, Kappert U, Mellert F, Shehada SE, Girdauskas E, Troise G, Solinas M, Minniti G, Mazzaro E, Rinaldi M, Pacini D, Argano V, Torella M, Lam KY, Micovic S, Siepe M, Baghai M, Lee SH, Choi JW, Je HG, Nobre A. Sex-Related Outcome After Sutureless Aortic Valve Replacement With Perceval Plus: Results From a Global Registry and Meta-Regression. Interdiscip Cardiovasc Thorac Surg. 2026 Jun 9;41(6):ivag170. doi: 10.1093/icvts/ivag170.
PubMed 42236299Dzemali 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.
PubMed 39666948Micovic 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.
PubMed 38902742
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting
- ClinicalTrials.gov ID
- NCT05002543
- Acronym / sponsor ID
- MANTRA / LNH800
- Conditions
- Cardiac Valve Disease
- Keywords
- Aortic Valve Replacement, Mitral Valve Replacement, Mitral Valve Repair, Tricuspid Valve Repair
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,150 participants (estimated)
- Lead sponsor
- Corcym S.r.lIndustry (pharma, biotech, devices)
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The MANTRA Master Plan (Master Protocol) is intended as an overarching Umbrella Protocol that allows multiple substudies 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
| 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 |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects diagnosed with heart valve disease who are considered suitable to undergo heart valve replacement/repair with a CORCYM device can be included
Key inclusion criteria (3 listed)
- Signed and dated approved Informed Consent
- 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)
Key exclusion criteria (3 listed)
- Subject is already participating to another clinical investigation that could confound the results of this clinical investigation.
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success
Time frame: 30 days
Device success at 30 days (+14 days) based on VARC-3, defined as: * Technical success * Freedom from mortality * Freedom from surgery or intervention related to the device or to a major vascular or access-related or cardiac structural complication * Intended performance of the valve (mean gradient<20 mmHg and less than moderate aortic regurgitation) The number and percentage of subjects with device success at 30 days as per VARC-3 definition, along with individual component of the success, will be presented.
The primary endpoint in the MITRAL/TRICUSPID Sub-study is number and percentage of subjects with Device Success
Time frame: 30 days
Device success at 30 days (+14 days) based on MVARC, defined as: * Procedural mortality or stroke AND * Proper placement and positioning of the device AND * Freedom from unplanned surgical or interventional procedures related to the device or access procedure AND * Continued intended safety and performance of the device, including: * Evidence of structural or functional failure * Specific device-related technical failure issues and complications * MITRAL: Reduction of Mitral Regurgitation (MR) to either optimal or acceptable levels (site-reported) * TRICUSPID: Reduction of Tricuspid Regurgitation (TR) to either optimal or acceptable levels (site-reported) Number and percentage of subjects with device success, along with individual component, will be presented.
The primary endpoint in the MEMO 4D Sub-study is number and percentage of subjects with Device Success
Time frame: 30 days
Device success at 30 days (+14 days) based on the MVARC, defined as: * Procedural mortality or stroke; AND * Proper placement and positioning of the device; AND * Freedom from unplanned surgical or interventional procedures related to the device or access procedure; AND * Continued intended safety and performance of the device, including: * Evidence of structural or functional failure * Specific device-related technical failure issues and complications * Reduction of Mitral Regurgitation (MR) to either optimal or acceptable levels without significant mitral stenosis (i.e., post-procedure EOA is ≥ 1.5 cm2 with a transmitral gradient <5 mmHg), and with no greater than mild MR core-lab assessed The number and percentage of subjects with device success at 30 days as per MVARC definition, along with individual component of the success, will be presented.
10 secondary outcomes
Mortality (all-cause mortality, cardiovascular mortality, device related mortality)
Time frame: up to 10 years from implant
Major Adverse Cardiovascular and Cerebrovascular Event (MACCE - composite endpoint of all cause death, myocardial infarction, stroke, and valve re-intervention)
Time frame: up to 10 years from implant
Re-hospitalization (all-cause re-hospitalization, cardiovascular re-hospitalization, device related re-hospitalization)
Time frame: up to 10 years from implant
Technical success
Time frame: intraoperatively
Clinical Efficacy (AORTIC sub-study)
Time frame: 12 months
Valve-related long-term clinical efficacy
Time frame: at 5 years and up to 10 years
Bioprosthetic Valve Dysfunction (BVD), including Structural Valve Deterioration (SVD), Non structural valve dysfunction (NSVD), Thrombosis and Endocarditis
Time frame: up to 10 years from implant
Patient outcome (Kansas City Cardiomyopathy Questionnaire (KCCQ-12); and EQ-5D-5L (in patients treated with Perceval Plus)
Time frame: 12 months
Patient outcome (New York Heart Association (NYHA) Classification)
Time frame: up to 10 years from implant
Hemodynamic and structural performance
Time frame: up to 10 years from implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Derived from this study: PubMed 42236299Santarpino G, Lorusso R, Di Mauro M, D'Anna V, Prencipe CM, Voisine P, Bisleri G, Parrino E, Bates M, Hughes GC, Roselli E, Baeza C, Heimansohn D, Bove T, Meuris B, Gutermann H, Corbi P, Pollari F, Awad G, Kappert U, Mellert F, Shehada SE, Girdauskas E, Troise G, Solinas M, Minniti G, Mazzaro E, Rinaldi M, Pacini D, Argano V, Torella M, Lam KY, Micovic S, Siepe M, Baghai M, Lee SH, Choi JW, Je HG, Nobre A. Sex-Related Outcome After Sutureless Aortic Valve Replacement With Perceval Plus: Results From a Global Registry and Meta-Regression. Interdiscip Cardiovasc Thorac Surg. 2026 Jun 9;41(6):ivag170. doi: 10.1093/icvts/ivag170.
- Derived from this study: PubMed 39666948Dzemali 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.
- Derived from this study: PubMed 38902742Micovic 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Gaggianesi study director
Corcym S.r.l
52 sites in 13 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Valve Disease, run by Corcym S.r.l at 52 sites in 13 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 52 sites in Italy, United States, Germany, France, Belgium and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Dipinto (+39 346 1284042, silvia.dipinto@corcym.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint in the AORTIC Sub-study is number and percentage of subjects with Device Success (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05002543, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.