NCT02272621

Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Aortic Valve Stenosis
• Heart Valve Diseases

Interventions

Type	Name	Description
PROCEDURE	Minimally invasive aortic valve replacement
PROCEDURE	Full sternotomy aortic valve replacement

Timeline

• Start date: 2013-11-01
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2014-10-23
• Last updated: 2021-06-02

Locations

1 site across 1 country: Sweden