Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis; Heart Valve Diseases
• Interventions: Procedure: Minimally invasive aortic valve replacement; Procedure: Full sternotomy aortic valve replacement

• Registration Number: NCT02272621
• Lead Sponsor: Karolinska University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-23
• Primary Completion: 2020-10
• Study Completion: 2020-10
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-31
• Last Update Posted: 2021-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Partial upper hemisternotomy aortic valve replacement	Minimally invasive aortic valve replacement	Partial upper hemisternotomy AVR will be performed according to current standard of care practices.
Full sternotomy aortic valve replacement	Full sternotomy aortic valve replacement	Full sternotomy AVR through a standard median sternotomy will be performed according to current standard of care practices.

Primary Outcome Measures

Name	Time	Method
Universal definition of perioperative bleeding in adult cardiac surgery	Within 3 days from surgery

Trial Locations

Locations (1)

Department of Cardiothoracic Surgery, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden