The MANTRA study: a new umbrella concept prospectively applied to assess implantable medical devices for heart valve procedures.

Autor: Meuris B; University Hospital Leuven, Gasthuisberg Herestraat 49, 3000, Leuven, Belgium., Günaydın S; Ankara City Hospital Üniversiteler Mahallesi, 1604 Cadde No: 9, Çankaya, Ankara, Turkey., Lancellotti P; University Hospital Liège, CHU Sart Tilman, Avenue de l'hôpital, 1, 4000, Liège, Belgium., Badano L; 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 G; Division of Cardiothoracic Surgery, University of Washington, Seattle, WA, USA., Herrenknecht R; Corcym S.R.L, Via Giovanni Spadolini 7, 20141, Milan, Italy., Cerutti E; Corcym S.R.L, Via Giovanni Spadolini 7, 20141, Milan, Italy. elisa.cerutti@corcym.com., Gaggianesi S; Corcym S.R.L, Via Giovanni Spadolini 7, 20141, Milan, Italy., Dipinto S; Corcym S.R.L, Via Giovanni Spadolini 7, 20141, Milan, Italy., Morando P; Corcym S.R.L, Via Giovanni Spadolini 7, 20141, Milan, Italy., Kempfert J; Klinik für Herz-, Thorax- und Gefäßchirurgie Deutsches Herzzentrum der Charité, Augustenburger Platz 1, 13353, Berlin, Germany.
Jazyk: angličtina
Zdroj: Journal of cardiothoracic surgery [J Cardiothorac Surg] 2023 Apr 07; Vol. 18 (1), pp. 110. Date of Electronic Publication: 2023 Apr 07.
DOI: 10.1186/s13019-023-02270-w
Abstrakt: 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.
(© 2023. The Author(s).)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje