CORCYM Mitral, Aortic aNd Tricuspid Post-maRket Study in a reAl-world Setting

NCT05002543 | Recruiting

• 1 other identifier: LNH800
• Study Type: observational
• Target: 2,150
• Locations: 13 countries
• Sites: 52

Brief 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

Conditions

Cardiac Valve Disease

Keywords

Aortic Valve Replacement; Mitral Valve Replacement; Mitral Valve Repair; Tricuspid Valve Repair

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  30 days

Secondary Outcomes (10)

• Mortality (all-cause mortality, cardiovascular mortality, device related mortality)

  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)

  up to 10 years from implant

• Re-hospitalization (all-cause re-hospitalization, cardiovascular re-hospitalization, device related re-hospitalization)

  up to 10 years from implant

• Technical success

  intraoperatively

• Clinical Efficacy (AORTIC sub-study)

  12 months

Study Arms (3)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Corcym S.r.l: lead

Study Sites (52)

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, 46290, United States

RECRUITING

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

RECRUITING

Maine Medical Center

Portland, Maine, 04102, United States

WITHDRAWN

Duke University

Durham, North Carolina, 27710, United States

RECRUITING

East Carolina University

Greenville, North Carolina, 27858, United States

RECRUITING

University Hospitals Cleveland

Cleveland, Ohio, 44106, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Lankenau Institute for Medical Research

Wynnewood, Pennsylvania, 19096, United States

ACTIVE NOT RECRUITING

Innsbruck Medical University

Innsbruck, 6020, Austria

RECRUITING

Ziekenhuis Oost Limburg

Genk, 3600, Belgium

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

UZ Leuven

Leuven, 3000, Belgium

RECRUITING

University of Calgary (Foothills Hospital)

Calgary, 1403, Canada

RECRUITING

Hospital Laval IUCPQ

Québec, G1V 4G5, Canada

RECRUITING

St. Michael's Hospital

Toronto, M5B 1W8, Canada

RECRUITING

CHU Clermont-Ferrand_Hopital Gabriel Montpied

Clermont-Ferrand, F-63003, France

ACTIVE NOT RECRUITING

Centre Hospitalier de Lens

Lens, 62300, France

RECRUITING

CHU Poitiers

Poitiers, 86021, France

RECRUITING

CHU Toulouse_Rangueil University Hospital

Toulouse, 31059, France

RECRUITING

Universitätsklinikum Augsburg

Augsburg, 86156, Germany

ACTIVE NOT RECRUITING

Kerckhoff Klinik

Bad Nauheim, 61231, Germany

RECRUITING

Deutsches Herzzentrum Berlin

Berlin, 13353, Germany

RECRUITING

Herzzentrum Dresden Universitätsklinik

Dresden, 1307, Germany

RECRUITING

Universitätsklinikum Essen

Essen, 45147, Germany

RECRUITING

Universitätsklinikum Magdeburg

Magdeburg, 39120, Germany

RECRUITING

Klinikum Nürnberg

Nuremberg, 90471, Germany

RECRUITING

Klinikum Oldenburg GGMBH AöR

Oldenburg, 26133, Germany

RECRUITING

Ospedale Riuniti Ancona

Ancona, 60126, Italy

RECRUITING

Policlinico S.Orsola-Malpighi

Bologna, 40138, Italy

RECRUITING

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

RECRUITING

Ospedale Città di Lecce

Lecce, 73100, Italy

RECRUITING

Ospedale del Cuore "G. Pasquinucci"

Massa, 54100, Italy

RECRUITING

IRCCS Policlinico San Donato

Milan, 20097, Italy

RECRUITING

Azienda ospedaliera dei Colli - Ospedale Monaldi

Napoli, 80131, Italy

RECRUITING

Policlinico Paolo Giaccone

Palermo, 90127, Italy

RECRUITING

A.O.U. Citta della Salute e della Scienza di Torino - Ospedale Molinette

Torino, 10126, Italy

RECRUITING

Ospedale Cà Foncello di Treviso

Treviso, 31100, Italy

RECRUITING

Az. Ospedaliero-Universitaria "Ospedali Riuniti" di Trieste

Trieste, 34129, Italy

RECRUITING

Ospedale San Bortolo

Vicenza, 36100, Italy

RECRUITING

Catharina Ziekenhuis

Eindhoven, 5623, Netherlands

RECRUITING

UMC Groningen

Groningen, 9713, Netherlands

ACTIVE NOT RECRUITING

Hospital de Santa Maria Lisbon

Lisbon, 1649-028, Portugal

RECRUITING

Dedinje Cardiovascular Institute

Belgrade, 11040, Serbia

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Yonsei University Severance Cardiovascular Hospital

Seoul, 3722, South Korea

RECRUITING

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

RECRUITING

Inselspital, Universitätsspital Bern

Bern, CH-3010, Switzerland

RECRUITING

Stadtspital Triemli

Zurich, 8063, Switzerland

RECRUITING

Queen Elisabeth Medical Centre

Birmingham, B15 2TH, United Kingdom

RECRUITING

Bristol Royal Infirmary

Bristol, BS2 8HW, United Kingdom

RECRUITING

King's College Hospital

London, SE5 9RS, United Kingdom

RECRUITING

Related Publications (2)

• 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.

  PMID: 39666948 DERIVED

• 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.

  PMID: 38902742 DERIVED

MeSH Terms

Conditions

Heart Valve Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sara Gaggianesi

  Corcym S.r.l

  STUDY DIRECTOR

Central Study Contacts

Silvia Dipinto

CONTACT

+39 346 1284042; silvia.dipinto@corcym.com

Michela Paroli

CONTACT

+39 348; michela.paroli@corcym.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 12, 2021
• Study Start: June 29, 2021
• Primary Completion: August 30, 2025
• Study Completion (Estimated): December 31, 2035
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

AU (1); DE (8); SE (1); CH (2); FR (4); KR (3); NL (2); US (9); GB (3); BE (3); CA (3); IT (12); PT (1)