Recruiting

CORCYM

Sponsor:

Corcym S.r.l

Code:

NCT05002543

Conditions

Cardiac Valve Disease

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05002543

Start date

Jun 29, 2021

Status verified date

Mar, 2024

Completion date

Dec 31, 2035

Anticipated

Primary completion date

Aug 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Design

Enrollment

2150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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 primary endpoint in the MITRAL/TRICUSPID Sub-study is number and percentage of subjects with Device Success [ Time Frame: 30 days ]
  • The primary endpoint in the MEMO 4D Sub-study is number and percentage of subjects with Device Success [ Time Frame: 30 days ]

Central Contacts and Locations

Central contacts

Silvia Dipinto

+39 346 1284042silvia.dipinto@corcym.com

Michela Paroli

+39 348michela.paroli@corcym.com

Locations

St. Vincent Heart Center of Indiana

Recruiting

Indianapolis, Indiana, United States, 46290

Contacts

David Heimansohn

david.heimansohn@ascension.org

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Eugene Parrino

eparrino@ochsner.org

Duke University

Recruiting

Durham, North Carolina, United States, 27710

Contacts

G. Chad Hughes

gchad.hughes@duke.edu

East Carolina University

Recruiting

Greenville, North Carolina, United States, 27858

Contacts

Michael Bates

batesm19@ecu.edu

University Hospitals Cleveland

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Christian Baeza

cristian.baeza@uhhospitals.org

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Eric Roselli

ROSELLE@ccf.org

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Joseph Bavaria

joseph.bavaria@pennmedicine.upenn.edu

University of Calgary (Foothills Hospital)

Recruiting

Calgary, Canada, 1403

Contacts

William Kent

William.Kent@albertahealthservices.ca

Hospital Laval IUCPQ

Recruiting

Québec, Canada, G1V 4G5

Contacts

Pierre Voisine

pierre.voisine@criucpq.ulaval.ca

St. Michael's Hospital

Recruiting

Toronto, Canada, M5B 1W8

Contacts

Gianluigi Bisleri

gianluigi.bisleri@unityhealth.to

More Information

Sponsor

Corcym S.r.l

Last update posted

Mar 6, 2024

Last verified

Mar, 2024

Keywords

  • Aortic Valve Replacement
  • Mitral Valve Replacement
  • Mitral Valve Repair
  • Tricuspid Valve Repair

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Corcym S.r.l on 2024-03-06.