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Monitoring the safety and performance of CORCYM heart valve devices

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

Corcym S.r.l · NCT05002543

This study is looking to see how safe and effective CORCYM heart valve devices are for people with aortic, mitral, and tricuspid valve diseases over the next 10 years.

Quick facts

Study typeObservational
Enrollment2150 (estimated)
SexAll
SponsorCorcym S.r.l (industry)
Locations52 sites (Indianapolis, Indiana and 51 other locations)
Trial IDNCT05002543 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals eligible for treatment with CORCYM aortic, mitral, and/or tricuspid devices.

Not a fit: Patients with a life expectancy of 12 months or less or those with contraindications to CORCYM devices may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term safety and effectiveness of CORCYM heart valve devices, potentially improving patient outcomes.

How similar studies have performed: Other studies assessing the performance of cardiac devices have shown success, indicating that this approach is supported by prior research.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Indianapolis, Indiana and 51 other locations

+2 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Cardiac Valve Disease, Aortic Valve Replacement, Mitral Valve Replacement, Mitral Valve Repair, Tricuspid Valve Repair

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.