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NCT02272621 Clinical Trial

Bleeding in Partial Upper Hemisternotomy Versus Full Sternotomy Aortic Valve Replacement

Aortic Valve Stenosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02272621
Other study ID # CMILE-bleeding
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2013
Est. completion date October 2020

Study information
Verified date May 2021
Source Karolinska University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date October 2020
Est. primary completion date October 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Minimally invasive aortic valve replacement

• Full sternotomy aortic valve replacement

Locations
Country Name City State
Sweden Department of Cardiothoracic Surgery, Karolinska University Hospital Stockholm

Sponsors (2)
Lead Sponsor Collaborator
Karolinska University Hospital Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Universal definition of perioperative bleeding in adult cardiac surgery Within 3 days from surgery
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