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

NCT05002543 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 2150

Last updated 2024-03-06

No results posted yet for this study

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

Sponsors & Collaborators

  • Corcym S.r.l

    lead INDUSTRY

Principal Investigators

  • Sara Gaggianesi · Corcym S.r.l

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2025-08-30
Completion
2035-12-31

Countries

  • United States
  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Netherlands
  • Portugal
  • Serbia
  • South Korea
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05002543 on ClinicalTrials.gov