A pragmatic, prospective, randomised controlled trial comparing upper ministernotomy to full median sternotomy as a surgical approach for aortic valve replacement

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN58128724

Enrollment

240

Registered

2010-06-24

Start date

2009-11-30

Completion date

Unknown

Last updated

2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Cardiovascular, Generic Health Relevance and Cross Cutting Themes

Interventions

Comparing upper mini-sternotomy to full median sternotomy as a surgical approach to first time isolated aortic valve replacement (AVR).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged greater than 18 years at the time of surgery, either sex 2. Elective, first time, isolated aortic valve replacement (AVR)

Exclusion criteria

Exclusion criteria: 1. Documented poor left ventricular (LV) function or left ventricular ejection fraction (LVEF) 30% 2. Documented chest wall deformities 3. Documented severe emphysema or chronic obstructive pulmonary disease (COPD) 4. Current body mass index (BMI) greater than 35 kg/m^2 5. Concomitant cardiac surgery 6. Redo surgery 7. Median sternotomy indicated

Design outcomes

Primary

Measure	Time frame
Total length of stay in hospital for the index AVR operation measured in days	—

Secondary

Measure	Time frame
1. Fitness for discharge 2. Health related quality of life and patient satisfaction at baseline, 6 weeks, 6 months and 12 months using the 36-item short form health survey (SF-36) and Coronary Revascularization Outcome Questionnaire - Coronary Artery Bypass Graft (CROQ-CABG) 3. Heart function (LVEF) by echocardiography at baseline, day of discharge and 6 months post surgery 4. Procedure time: total theatre time, cross clamp time, cardiopulmonary bypass time, blood loss, blood transfusion 5. Respiratory function (forced expiratory volume in one second [FEV1]) by hand held spirometry at baseline, day 4, day of discharge, 6 weeks and 6 months	—

Measure

Time frame

1. Fitness for discharge 2. Health related quality of life and patient satisfaction at baseline, 6 weeks, 6 months and 12 months using the 36-item short form health survey (SF-36) and Coronary Revascularization Outcome Questionnaire - Coronary Artery Bypass Graft (CROQ-CABG) 3. Heart function (LVEF) by echocardiography at baseline, day of discharge and 6 months post surgery 4. Procedure time: total theatre time, cross clamp time, cardiopulmonary bypass time, blood loss, blood transfusion 5. Respiratory function (forced expiratory volume in one second [FEV1]) by hand held spirometry at baseline, day 4, day of discharge, 6 weeks and 6 months

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026