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

Recruiting now

Conditions studied: Cardiac Valve Disease

In brief

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

Key facts

Study ID

NCT05002543

Run by

Corcym S.r.l

People needed

2150

Starts

2021-06-29

Expected to finish

2035-12-31

Last updated by the study team

2024-03-06

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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 is running

• Klinikum Oldenburg GGMBH AöR — Oldenburg, Germany (enrolling)
• St. Vincent Heart Center of Indiana — Indianapolis, Indiana, United States (enrolling)
• Universitätsklinikum Magdeburg — Magdeburg, Germany (enrolling)
• Klinikum Nürnberg — Nuremberg, Germany (enrolling)
• University Hospitals Cleveland — Cleveland, Ohio, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States (enrolling)
• Duke University — Durham, North Carolina, United States (enrolling)
• East Carolina University — Greenville, North Carolina, United States (enrolling)
• Ziekenhuis Oost Limburg — Genk, Belgium (enrolling)
• UZ Gent — Ghent, Belgium (enrolling)
• UZ Leuven — Leuven, Belgium (enrolling)
• University of Calgary (Foothills Hospital) — Calgary, Canada (enrolling)
• Hospital Laval IUCPQ — Québec, Canada (enrolling)
• St. Michael's Hospital — Toronto, Canada (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Centre Hospitalier de Lens — Lens, France (enrolling)
• CHU Poitiers — Poitiers, France (enrolling)
• CHU Toulouse_Rangueil University Hospital — Toulouse, France (enrolling)
• Innsbruck Medical University — Innsbruck, Austria (enrolling)
• Kerckhoff Klinik — Bad Nauheim, Germany (enrolling)
• Deutsches Herzzentrum Berlin — Berlin, Germany (enrolling)
• Herzzentrum Dresden Universitätsklinik — Dresden, Germany (enrolling)
• Universitätsklinikum Essen — Essen, Germany (enrolling)
• Ospedale Riuniti Ancona — Ancona, Italy (enrolling)

Full record on ClinicalTrials.gov

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