Article (Scientific journals)
The MANTRA study: a new umbrella concept prospectively applied to assess implantable medical devices for heart valve procedures.
Meuris, Bart; Günaydın, Serdar; Lancellotti, Patrizio et al.
2023In Journal of Cardiothoracic Surgery, 18 (1), p. 110
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Keywords :
And tricuspid heart valve; Aortic valve; Medical devices; Mitral valve; Study design; Humans; Follow-Up Studies; Prospective Studies; Prostheses and Implants; Treatment Outcome; Heart Valve Diseases/surgery; Heart Valve Prosthesis/adverse effects; Heart Valve Prosthesis Implantation/instrumentation; Heart Valve Prosthesis Implantation/methods; Heart Valves/surgery; Cardiac Surgical Procedures; Heart Valve Diseases; Heart Valve Prosthesis Implantation; Heart Valves; Surgery; Pulmonary and Respiratory Medicine; Cardiology and Cardiovascular Medicine; General Medicine
Abstract :
[en] [en] BACKGROUND: Clinical evidence is commonly obtained through individual trials that are time-, cost- and resource-consuming, and which often leave unanswered clinically relevant questions. Umbrella studies have been developed to address the need for more efficient and flexible trial structures, predominantly for cancer treatments. The umbrella concept foresees data collection within a unifying trial structure, to which one or more substudies may be added at any time to address product- or therapy-specific questions. To our knowledge, the umbrella concept has not yet been used in the medical device area, but it may offer similar advantages as in other settings, particularly in areas where multiple therapies are available within one large treatment area. METHODS: The MANTRA study (NCT05002543) is a prospective, global, post-marketing clinical follow-up study. The aim is to collect safety and device performance data covering the Corcym cardiac surgery portfolio for the treatment of aortic, mitral, and tricuspid valve diseases. The study uses a master protocol that outlines the main common parameters, and the specific questions are addressed in three substudies. The primary endpoints are device success at 30 days. Secondary endpoints include safety- and device performance-related data at 30 days, 1 year, and then annually through to 10 years. All endpoints are defined according to the more recent guidelines for heart valve procedures. Additionally, procedure and hospitalization information are collected, including Enhanced Recovery after Surgery in sites using such protocols, and patient outcome measures such as New York Heart Association classification and quality-of-life questionnaires. RESULTS: The study started in June 2021. Enrollment in all three substudies is ongoing. CONCLUSIONS: The MANTRA study will provide contemporary information on the long-term outcomes of medical devices for the treatment of aortic, mitral, and tricuspid heart valve diseases in routine clinical practice. The umbrella approach adopted in the study has the potential of longitudinally assessing long-term efficacy of the devices and the flexibility to investigate new research questions as they arise.
Disciplines :
Cardiovascular & respiratory systems
Author, co-author :
Meuris, Bart;  University Hospital Leuven, Gasthuisberg Herestraat 49, 3000, Leuven, Belgium
Günaydın, Serdar;  Ankara City Hospital Üniversiteler Mahallesi, 1604 Cadde No: 9, Çankaya, Ankara, Turkey
Lancellotti, Patrizio  ;  Centre Hospitalier Universitaire de Liège - CHU > > Service de cardiologie
Badano, Luigi;  Department of cardiology, Istituto Auxologico Italiano, IRCCS, Piazzale Brescia, 20, 20149, Milan, Italy ; Department of medicine and surgery, University of Milano-Bicocca, Piazza Ateneo Nuovo 1, 20126, Milan, Italy
Aldea, Gabriel;  Division of Cardiothoracic Surgery, University of Washington, Seattle, WA, USA
Herrenknecht, Rita;  Corcym S.R.L, Via Giovanni Spadolini 7, 20141, Milan, Italy
Cerutti, Elisa;  Corcym S.R.L, Via Giovanni Spadolini 7, 20141, Milan, Italy.
Gaggianesi, Sara;  Corcym S.R.L, Via Giovanni Spadolini 7, 20141, Milan, Italy
Dipinto, Silvia;  Corcym S.R.L, Via Giovanni Spadolini 7, 20141, Milan, Italy
Morando, Paola;  Corcym S.R.L, Via Giovanni Spadolini 7, 20141, Milan, Italy
Kempfert, Jörg;  Klinik für Herz-, Thorax- und Gefäßchirurgie Deutsches Herzzentrum der Charité, Augustenburger Platz 1, 13353, Berlin, Germany
Language :
Title :
The MANTRA study: a new umbrella concept prospectively applied to assess implantable medical devices for heart valve procedures.
Publication date :
07 April 2023
Journal title :
Journal of Cardiothoracic Surgery
Publisher :
BioMed Central Ltd, England
Volume :
Issue :
Pages :
Peer reviewed :
Peer Reviewed verified by ORBi
Funding text :
The MANTRA study is funded by Corcym S.r.l
Available on ORBi :
since 25 May 2023


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