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

Launched by CORCYM S.R.L · Aug 4, 2021

Keywords

ClinConnect Summary

The CORCYM Mitral, Aortic, and Tricuspid Post-market Study, also known as the MANTRA trial, is focused on checking the safety and effectiveness of certain heart valve devices made by CORCYM. These devices are used for treating issues with the aortic, mitral, and tricuspid valves in the heart. This study is taking place in multiple locations around the world and aims to gather real-world data on how well these devices work after they have been approved for use.

To participate in this study, individuals must be eligible for treatment with the CORCYM devices and must agree to follow the study's follow-up schedule. They should be able to provide informed consent and not be involved in any other clinical studies that might affect the results. Participants can expect regular check-ups to monitor their health and the performance of the devices over time. Overall, this trial aims to provide valuable information about how these heart valve solutions perform in everyday clinical settings, helping doctors and patients make informed decisions about treatment options.

Gender

ALL

Eligibility 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)