Minimally invasive thoracoscopically-guided right minithoracotomy versus conventional sternotomy for mitral valve repair: a multicentre randomised controlled trial (UK Mini Mitral).

South Tees Hospitals NHS Foundation Trust0 个研究点目标入组 330 人开始时间: 2016年9月12日最近更新: 2023年6月26日

适应症

试验速览

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33853807/ (added 16/04/2021) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37314276/ (added 15/06/2023)

•1. Adult (=18 years old at consent) patients with degenerative mitral valve disease, requiring isolated MVr (patients requiring concomitant surgery for Atrial Fibrillation and/or Patent Foramen Ovale (PFO) closure will be included)
•2. Written informed consent
•3. Fit for cardiac surgery and cardiopulmonary bypass

•1. Concomitant cardiac surgery other than AF ablation and PFO closure
•2. Requiring mitral valve replacement
•3. Acute infective endocarditis
•4. Emergency or salvage surgery
•5. Only conventional median sternotomy or only minimally invasive surgery indicated
•6. Pregnant*
•7. Currently participating in another interventional clinical trial
•8. Four weeks or more as an inpatient prior to randomisation
•9. Previous cardiac surgery
•*Female patients between the ages of 18 and 50 will receive a pregnancy test at baseline

发起方