Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

Karolinska University Hospital

Status: Completed

Conditions: Heart Valve Diseases; Aortic Valve Stenosis

Treatments: Procedure: Full sternotomy aortic valve replacement; Procedure: Minimally invasive aortic valve replacement

Study type: Interventional

Funder types: Other

Identifiers

NCT02272621

CMILE-bleeding

Details and patient eligibility

About

This is a single-center, open-label, randomized controlled trial. Patients scheduled for aortic valve replacement (AVR) at Karolinska University Hospital in Stockholm, Sweden will be eligible. One-hundred patients will be randomly assigned to either partial upper sternotomy (50 patients) or full sternotomy AVR (50 patients). Inclusion criteria is severe aortic stenosis referred for medically indicated isolated aortic valve replacement. Exclusion criteria are inclusion in other trial, left ventricular ejection fraction less than 0.45, previous cardiac surgery, or urgent/emergent surgery.

Mechanical and bioprosthetic (stented or sutureless) aortic valves will be implanted. Clinical characteristics will be registered. Clinical postoperative outcomes including bleeding outcomes will be registered. Routine blood sampling will be performed pre- and postoperatively. All available data will be collected prospectively. Informed consent will be obtained from patients meeting the inclusion criteria before the initiation of any study-specific procedures.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years of age
• Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography
• Referred for medically indicated aortic valve replacement
• Sinus rhythm
• Provide written informed consent

Exclusion criteria

• Inclusion in other trial
• Left ventricular ejection fraction less than 0.45
• Presence of any coexisting severe valvular disorder
• Previous cardiac surgery
• Urgent or emergent surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Partial upper hemisternotomy aortic valve replacement

Experimental group

Description:

Partial upper hemisternotomy AVR will be performed according to current standard of care practices.

Treatment:

Procedure: Minimally invasive aortic valve replacement

Full sternotomy aortic valve replacement

Experimental group

Description:

Full sternotomy AVR through a standard median sternotomy will be performed according to current standard of care practices.

Treatment:

Procedure: Full sternotomy aortic valve replacement