NCT01972555 (CMILE).
Methods |
Study design: open‐label, randomised controlled trial Duration: 22 months No. of centres: single Location: Sweden Setting: cardiac surgical centre Dates: October 2013 to July 2015 |
Participants | 40 consecutive participants undergoing first‐time elective isolated AVR. Exclusion criteria: LVEF < 0.45; coexisting severe valvular disorder; previous cardiac surgery; urgent or emergent surgery |
Interventions | Limited sternotomy: either mini‐sternotomy or anterior right‐sided mini‐thoracotomy |
Outcomes |
Primary outcomes: tricuspid annular systolic plane excursion; right ventricular fractional area change; right ventricular dimensions; pulsed wave tissue Doppler right ventricular velocity (all at postoperative days 4 and 40) Secondary outcomes: not stated (follow‐up time in parentheses) |
Notes | Principle investigator contacted for results (October 2016). |
AVR: aortic valve replacement; COPD: chronic obstructive pulmonary disease; LVEF: left ventricular ejection fraction.