Monitoring the safety and performance of CORCYM heart valve devices

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The MANTRA study is a global, multi-center observational follow-up initiative designed to assess the safety and performance of CORCYM devices used in treating aortic, mitral, and tricuspid valve diseases. It aims to enroll approximately 2150 subjects across up to 130 sites worldwide, collecting data during heart valve procedures and follow-up visits over a period of up to 10 years. The study utilizes an overarching master protocol that allows for the addition of multiple sub-studies to enhance data collection and analysis. Participants will be monitored at discharge, 30 days post-implantation, and annually thereafter.

Why it matters

Who can join: the full rules

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)

Where it's running

• St. Vincent Heart Center of Indiana
  Indianapolis, Indiana, United States Recruiting
• Ochsner Clinic Foundation
  New Orleans, Louisiana, United States Recruiting
• Duke University
  Durham, North Carolina, United States Recruiting
• East Carolina University
  Greenville, North Carolina, United States Recruiting
• University Hospitals Cleveland
  Cleveland, Ohio, United States Recruiting
• Cleveland Clinic
  Cleveland, Ohio, United States Recruiting

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Silvia Dipinto
• Email: silvia.dipinto@corcym.com
• Phone: +39 346 1284042

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.