CORCYM, the new, independent, medical device company dedicated to providing patients and cardiac surgeons with the best solutions to fight structural heart disease, announces today the enrollment of the first patient in the MANTRA study. MANTRA (Mitral, Aortic aNd Tricuspid post-maRket Study in a reAl-world setting) is a prospective, multi-arm, multi-center, global, post-market clinical follow-up study that monitors the safety and performance of the complete CORCYM portfolio in a real-world setting.
“The MANTRA study has been designed leveraging the umbrella study concept, as it contains a master protocol with endpoints applicable across the treatment options together with additional sub-studies for specific devices and dedicated endpoints. MANTRA currently contains three sub-studies: an aortic study, a mitral and tricuspid study, and a third study fully dedicated to the Memo 4D annuloplasty ring,” explained Prof. Bart Meuris (University Hospital Leuven, Belgium) Coordinating Investigator of the MANTRA aortic sub-study and part of the MANTRA Steering Committee together with Prof. Serdar Günaydın (Ankara City Hospital, Turkey), Prof. Jörg Kempfert (Deutsches Herzzentrum Berlin, Germany) and Prof. Patrizio Lancellotti (University Hospital Liège, CHU Sart Tilman, Belgium).
The first patient was implanted in Italy, at Città di Lecce Hospital with a Bicarbon aortic mechanical valve, which has been CE mark approved for use with low-dose anticoagulant therapy in low-risk patients1. Conducted worldwide, the MANTRA study is planned to enroll 1,750 patients in approximately 100 centers with follow-up to 10 years.
“We are glad to take part in the MANTRA study and to have started enrolling patients in its aortic sub-study. As a primary endpoint, we will verify the device success at 30 days as defined by the VARC guidelines2. Study patients will be followed-up annually to 10 years to assess the device safety and performance, together with the patient quality of life,” reported Dr. Giuseppe Santarpino, Principal Investigator at Città di Lecce Hospital, Italy.
“The launch of the MANTRA study confirms CORCYM’s commitment to continuously generate new clinical evidence in collaboration with cardiac surgeons to help them treat patients better today and in the future,” commented Christian Mazzi, CORCYM CEO.
CORCYM is a global, independent, medical device company entirely focused on state-of-the-art surgical solutions to fight structural heart disease. CORCYM has a presence in more than 100 countries with approximately 850 employees and ensures strong continuous support to patients, healthcare professionals and healthcare systems worldwide. For more information, please visit www.corcym.com
- INR range 1.5-2.5 in patients at low risk for thromboembolic events undergoing single mechanical aortic valve replacement, as demonstrated by Torella et al., Am Heart J; 160:171-8, 2010.
- VARC: Valve Academic Research Consortium (Généreux, et al. 2021 Eur Heart J, 42(19):1825-1857).
For media information:
Marina Curci, CORCYM Communication