Here is the design of a clinical trial:

Official Title: Health-related Quality of Life, Satisfaction and Outcomes After Ministernotomy Versus Full Sternotomy Aortic Valve Replacement. A Randomized Controlled Trial (QUALITY-AVR TRIAL)

Included conditions:
- Aortic Valve Stenosis
- Heart Valve Diseases
- Aortic Valve Disease

Study Armgroups:
- {'label': 'ministernotomy', 'type': 'EXPERIMENTAL', 'description': 'Minimally invasive aortic valve replacement with Partial "J" upper hemisternotomy through right 4th intercostal space, performed according to current standard of care practice.', 'interventionNames': ['Procedure: ministernotomy']}
- {'label': 'full sternotomy', 'type': 'ACTIVE_COMPARATOR', 'description': 'Full sternotomy AVR through a standard median sternotomy, performed according to current standard of care practice.', 'interventionNames': ['Procedure: Full sternotomy']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'ministernotomy', 'description': 'Partial upper "J" hemisternotomy trough 4th right intercostal space)', 'armGroupLabels': ['ministernotomy']}
- {'type': 'PROCEDURE', 'name': 'Full sternotomy', 'description': 'Conventional full median sternotomy', 'armGroupLabels': ['full sternotomy']}

Primary Outcomes:
- {'measure': 'Differences between intervention groups in change from baseline Questionnaire EQ-5D-5L® Index at 1, 6 or 12 months', 'description': 'Questionnaire EQ-5D-5L® for quality of life', 'timeFrame': 'baseline-1-6-12 months'}

Please estimate the sample size based on the assumption: 
Alpha error of 0.05, beta error of 0.1, power of 90%, and a standard deviation of 0.15 for the EQ-5D-5L index were used for the calculations.
Sample size calculation
        A review of previous work [28, 29] shows that the standard deviations of the EQ-5D-5Â LÂ® index in cardiovascular disease varies between 0.10 and 0.22, while VAS score varies between 8 and 21 depending on the severity. Likewise, in the only (multicentre) study [17] that determines quality of life in aortic stenosis, the standard deviation for high-risk patients scheduled for AVR was 0.17 in patients randomised to FS versus TAVI. For these reasons, on summary of all previous work, we used a standard deviation of 0.15 for the EQ-5D-5Â LÂ® index to calculate the sample size.
        In QOL studies, it is not only important to ascertain whether there are significant differences, but also to know if these differences are clinically relevant. This is why the concept of the minimal important difference (MID) was created, which in previous research among patients with cancer was 0.08 points on the EQ-5D index and 7â11 points on the VAS [29], and in patients with stroke it was 0.10 points on the EQ-index (95% CI 0.08â0.12) [28]. This difference was also 0.06 points (95% CI 0.02â0.10) on the EQ index during the first month in the PARTNER 1 study (transfemoral TAVI versus FS) [17], and 0.12 (95% CI 0.08â0.16) in the CoreValve PIVOTAL trial study [18]. As there was no existing specific calculation of MID for cardiology patients with severe aortic stenosis, we arbitrarily established the interval of 0.10 points on the EQ-5D index (the mean value from previous studies) as the clinically relevant difference to detect. Thus, to detect an MID of at least 0.10 points in the QOL scale EQ-5D-5Â LÂ® index, with alpha error of 0.05, beta error of 0.1 and power of 90% for two-tailed contrast of two independent means (SD 0.15), two groups of 48 patients are necessary to provide a minimum of 96 patients. In view of possible losses to follow up, 100 patients will be randomised. If patients drop out or are excluded during the study, additional patients will be recruited until a minimum of 96 patients is achieved, and inclusion of an additional patient will be considered again for each patient not completing the 1-year follow-up assessment.