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

Recruitingn/aAges any - anyAllCorcym S.r.l
NCT05002543 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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, a

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📋 Eligibility rules (as published)
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)
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What it tests

  • Not listed
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Where

52 sites
St. Vincent Heart Center of Indiana
Indianapolis, United States
Ochsner Clinic Foundation
New Orleans, United States
Maine Medical Center
Portland, United States
Duke University
Durham, United States
East Carolina University
Greenville, United States
University Hospitals Cleveland
Cleveland, United States
Cleveland Clinic
Cleveland, United States
University of Pennsylvania
Philadelphia, United States

…and 44 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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