TY - JOUR JO - EuroIntervention TI - The MITRA-HR study: design and rationale of a randomised study of MITRACLIP® transcatheter mitral valve repair in patients with severe primary mitral regurgitation eligible for high-risk surgery AB - <p class="text-1er-paragraph"><span class="abstracts-titres">Aims:</span> Percutaneous mitral valve repair has become an alternative to conventional surgery in patients suffering primary mitral regurgitation (MR) with a contraindication to surgery and could benefit patients at high surgical risk. The aim of the MITRA-HR study is to raise the level of evidence supporting the use of the MitraClip® device in primary MR patients with a pre-defined high risk for surgery.<br/><br/><span class="abstracts-titres">Methods and results:</span> MITRA-HR is a prospective, multicentre, randomised study designed to compare mitral valve repair using MitraClip® with conventional surgery in patients with severe primary mitral regurgitation at high risk for surgery. The surgical risk is defined by age, Society of Thoracic Surgeons (STS) risk estimate score, frailty, major organ system dysfunction, and procedure-specific impediments. The study will enrol 330 patients randomised between conventional surgery and MitraClip® with a 1:1 ratio. The composite primary endpoint includes all-cause mortality, unplanned rehospitalisation for cardiovascular reasons, and mitral valve reintervention at 12 months. The main secondary safety endpoint is a major adverse event composite assessment evaluated 30 days after the procedure.<br/><br/><span class="abstracts-titres">Conclusions:</span> The randomised MITRA-HR study is designed to provide additional supportive evidence of non-inferiority in efficacy and superiority in safety for percutaneous mitral valve repair using MitraClip® compared to conventional surgery in high surgical risk patients.</p> AU - Piriou Nicolas AU - Al Habash Ousama AU - Donal Erwan AU - Senage Thomas AU - Le Tourneau Thierry AU - Pattier Sabine AU - Guyomarch Béatrice AU - Roussel Jean AU - Trochu Jean-Noël AU - Vahanian Alec AU - Obadia Jean-François AU - Iung Bernard AU - Guérin Patrice VL - IS - Y1 - 16/04/2019 Y1 - 2019 DOI - 10.4244/EIJ-D-18-01086 SP - KW - mitral regurgitation KW - mitral valve repair KW - clinical trials PB - Europa Digital & Publishing UR - https://eurointervention.pcronline.com/article/the-mitra-hr-study-design-and-rationale-of-a-randomised-study-of-mitraclipreg-transcatheter-mitral-valve-repair-in-patients-with-severe-primary-mitral-regurgitation-eligible-for-high-risk-surgery SN - 1774-024X ER -