Newcastle Clinical Trials Unit

UK Mini Mitral

UK Mini Mitral

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

Study stage: Recruiting
Sponsor: South Tees NHS Hospitals Foundation Trust
Funder: NIHR HTA
Therapeutic area: Cardiovascular
Type of study: Surgical

Aim: To determine if physical functioning and associated return to usual activities improves in patients who undergo mitral valve repair via minimally invasive thoracoscopically-guided right minithoracotomy compared to conventional sternotomy at 12 weeks.

Primary outcome:  Change in SF-36v2 physical functioning scale (1) at 12 weeks following surgery.

Primary economic outcome: incremental cost per QALY gained at 52 weeks following surgery.

Population: Adults
Design: Randomised Control Trial (RCT)
Setting: Secondary Care
Planned Sample Size: 316