RECRUITING

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

Description

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
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Related Conditions:

Cardiac Valve Disease

Study Overview

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Study Details

Study overview

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

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

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

Condition
Cardiac Valve Disease
Intervention / Treatment

-

Contacts and Locations

Indianapolis

St. Vincent Heart Center of Indiana, Indianapolis, Indiana, United States, 46290

New Orleans

Ochsner Clinic Foundation, New Orleans, Louisiana, United States, 70121

Portland

Maine Medical Center, Portland, Maine, United States, 04102

Durham

Duke University, Durham, North Carolina, United States, 27710

Greenville

East Carolina University, Greenville, North Carolina, United States, 27858

Cleveland

University Hospitals Cleveland, Cleveland, Ohio, United States, 44106

Cleveland

Cleveland Clinic, Cleveland, Ohio, United States, 44195

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Wynnewood

Lankenau Institute for Medical Research, Wynnewood, Pennsylvania, United States, 19096

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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)

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Corcym S.r.l,

Sara Gaggianesi, STUDY_DIRECTOR, Corcym S.r.l

Study Record Dates

2035-12-31