Brief Title
Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement
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.
Study Type
Interventional
Primary Outcome
Universal definition of perioperative bleeding in adult cardiac surgery
Condition
Aortic Valve Stenosis
Intervention
Minimally invasive aortic valve replacement
Study Arms / Comparison Groups
Partial upper hemisternotomy aortic valve replacement
Description: Partial upper hemisternotomy AVR will be performed according to current standard of care practices.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
100
Start Date
November 2013
Completion Date
October 2020
Primary Completion Date
October 2020
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT02272621
Organization ID
CMILE-bleeding
Responsible Party
Principal Investigator
Study Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
Study Sponsor
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Verification Date
May 2021